Medtronic Restore Medical, Inc.

  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7b1d6a781860a807c26a98b7d012899a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The study will be done for the following purposes:\n<ul>\n<li>to see if Pillar implants in combination with CPAP treatment can help people with their OSA by decreasing the CPAP pressures</li>\n<li>to find out if receiving Pillar implants will increase CPAP use</li>\n</ul>\n</p>', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:7b1d6a781860a807c26a98b7d012899a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:155fe9da056217cce83151bc75d385c7' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Randomized Placebo-Controlled Study of the Pillar&#174; Palatal Implant System With CPAP</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:155fe9da056217cce83151bc75d385c7' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5f0ba06c220bec0842906bee739821b8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The Pillar&#174; Palatal Implant System is designed to hold the airway open at night, thus avoiding obstruction. While the Pillar procedure can be effective in the treatment of mild to moderate OSA, its effect in combination with CPAP treatment has never been studied. In this study, the treatment of OSA using the Pillar procedure in combination with standard CPAP treatment vs. sham procedure in combination with standard CPAP treatment will be investigated. All subjects will be asked to continue their normal use of CPAP treatment during the study. The study will evaluate whether or not the Pillar implants allow less therapeutic pressure to be used in treating the OSA and if less pressure translates to increased usage.</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:5f0ba06c220bec0842906bee739821b8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ade6ff224aa3ad44d4db4110c5e54823' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>OSA documented by sleep study demonstrating AHI &gt; 10, where hypopneas are defined by Medicare criteria requiring a 4% desaturation</li>\n<li>Adequate CPAP therapy titration (residual AHI &lt; 5) resulting in a therapeutic pressure &#8805;7 cm H20 from baseline PSG</li>\n<li>Currently using or willing to change to Respironics CPAP device (without A-flex, C-flex and Bi-flex enabled) with SmartCard technology</li>\n<li>Currently dissatisfied with CPAP therapy</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Uses full face mask</li>\n<li>Soft palate length insufficient to accommodate 18mm implants as measured from the hard palate junction to the base of the uvula (&lt;25 mm)</li>\n<li>Drug abuse or alcoholism in the year prior to enrollment as assessed by history</li>\n<li>Inconsistent use of sleeping medications (1 or 2 nights per week)</li>\n</ul>\n</p>', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:ade6ff224aa3ad44d4db4110c5e54823' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:663405a9dd82be58a1f1ffc3c3c80176' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to research a new implant for the treatment of external nasal valve collapse (NVC). NVC is a condition which causes narrowness and weakness in the nostril which results in nasal obstruction. Implants will be placed in the affected nostril(s). The implants are intended to restore the shape and stabilize the nasal wall to prevent nasal valve collapse and improve the symptoms associated with nasal obstruction.</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:663405a9dd82be58a1f1ffc3c3c80176' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7ed4984b8989d48555718f63bd690197' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Open Label, Baseline Controlled Study to Evaluate the Use of Polyethylene Terepthalate (PET) Implants for the Treatment of External Nasal Valve Collapse and Cosmetic Contour Deformity</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:7ed4984b8989d48555718f63bd690197' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:71ae072517042237d9e93addcff736d7' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study is designed to evaluate a new polyethylene terepthalate implant for the treatment of uni-lateral and bilateral external nasal valve collapse and cosmetic contour deformity. The focus of this investigation will be to specifically address the lateral components of nasal valve collapse caused by weakened, distorted, or absent mechanical strength of the nasal cartilages or their fibrous attachments within the lateral nasal sidewall and nasal ala. The paired upper and lower cartilages within the lateral nasal sidewall have several features worth noting which contribute to the loss of support and are important to account for during surgical correction. The Primary Hypothesis, regarding safety and effectiveness, is as follows: The polyethylene terepthalate (PET) implants when inserted into the area of the compromised external nasal valve will result in improved nasal obstruction symptoms (static and dynamic external valve obstruction), improved cosmetic contour, and an adverse event profile that is no worse than currently available treatments.</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:71ae072517042237d9e93addcff736d7' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:90d886cf77eaf154415ee3b173eef9ae' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Positive response to any of the following based on patient history or office exam:\n<ul>\n<li>Breathe Rite Strips</li>\n<li>Q-Tip test</li>\n<li>Nasal stents</li>\n<li>Continuous manual distraction</li>\n</ul>\n</li>\n<li>Inspiratory lateral nasal wall collapse or static medially obstructing lateral nasal wall position identified on physical exam</li>\n<li>Nasal valve is narrow (either static or dynamic) based on a visual examination.</li>\n<li>Nasal septum is considered stable and adequate to support the treatment of each nasal valve independently.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Ability to achieve active nostril dilation and relieve obstruction using physiologic nasal alar and sidewall muscle actions</li>\n<li>Chronic or recurrent sinusitis leading to nasal obstruction</li>\n<li>Active nasal infection</li>\n<li>Skin inflammation in the nasal area</li>\n<li>Habitual chronic sniffers</li>\n<li>Allergies leading to nasal obstruction</li>\n<li>Septal Deviation believed to be causing obstruction</li>\n<li>Turbinate Hypertrophy believed to causing obstruction</li>\n<li>Polyps believed to causing obstruction</li>\n<li>Previous rhinoplasty of external nasal frame</li>\n<li>Ptotic Nose Tip believed to be causing obstruction</li>\n<li>Requires another surgery other than implants to correct the obstruction</li>\n<li>Nasal anatomy is inadequate to accommodate three 18mm implants</li>\n<li>Participating in a clinical study for another treatment for nasal valve collapse</li>\n<li>Previous surgery for external nasal valve collapse</li>\n<li>ASA rating of III or IV</li>\n<li>Any other condition believed to interfere with nasal assessments</li>\n</ul>\n</p>', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:90d886cf77eaf154415ee3b173eef9ae' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:22cc047805bcf754d0fd2ffb33973845' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The Pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe. The implants are placed into the soft area in the roof of the mouth providing support to the soft palate. This research is being done to compare daytime sleepiness and sleep related quality of life after palatal implants.</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:22cc047805bcf754d0fd2ffb33973845' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:205a790502368d47a5f79651c7b11894' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:205a790502368d47a5f79651c7b11894' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9597c4bb2697befd296a52c64137929a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Patients will be enrolled into the study based on sleep study results, a physical exam and inclusion/exclusion criteria. Once enrolled, patients are randomized into either the Pillar palatal implant group or a placebo/sham group. In both cases, patients come into the office for placement of the implants. This is an outpatient procedure. Patients are followed at one week, one month and 3 months. At each follow-up visit, patients will undergo a physical exam and complete questionnaires related to sleep and quality of life. Patients will also undergo reaction time testing on hand-held device similar to a pocket video game. At the three month visit, patients will return to the sleep lab for another sleep study.</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:9597c4bb2697befd296a52c64137929a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:156fae76cc5c14348c8191feb2614e01' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>18 years or older</li>\n<li>Body Mass Index equal to 32 or less</li>\n<li>Apnea-Hypopnea Index greater than/equal to 10 and less than/equal to 30</li>\n<li>Symptoms of daytime sleepiness</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Septal deviation or nasal obstruction</li>\n<li>Nasal polyps</li>\n<li>Severe seasonal allergies</li>\n<li>Soft palate length insufficient to accommodate implants</li>\n<li>Fujita Modified Mallampati Class 3</li>\n<li>Large tonsils</li>\n<li>Lingual tonsil hypertrophy</li>\n<li>Hypopharyngeal obstruction</li>\n<li>Previous pharyngeal surgery</li>\n<li>Previous upper respiratory tract cancer or radiation therapy</li>\n<li>Active respiratory tract infection</li>\n<li>Dysphagia or speech disorder</li>\n<li>Neurologic disorder</li>\n<li>Unstable psychiatric disorder</li>\n<li>Pregnant or breastfeeding</li>\n<li>History of falling asleep driving or MVA due to sleepiness</li>\n<li>Currently on CPAP therapy or other device for OSA</li>\n<li>Other sleep disorders</li>\n</ul>\n</p>', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:156fae76cc5c14348c8191feb2614e01' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Daytime Sleepiness (ESS)</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:f73518b257255d98bac7ed966c5bafef' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Apnea/Hypopnea Index (AHI)</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:fc97535b0eecb00d166527368e71ea86' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Sleep Related Quality of Life (FOSQ)</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:e0d66ac5e28acfe893abff28eb08c69a' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Reaction Time Testing (PVT)</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:41e02b5453e2fba7445f4b7986c12dca' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:3f0d0df9112ee0e53d60654274158589' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of the study is to compare the effectiveness of soft palatal implants with placebo and continuous positive airway pressure treatment in obstructive sleep apnea.</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:c5dbe2555f7c4fda1bc361032c472353' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Randomized, Controlled Treatment Trial of Soft Palatal Implants and Positive Airway Pressure in Mild to Moderate Obstructive Sleep Apnea and Snoring</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:083448df4e18ee43b2221e1f45e315e3' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8165654f0586c53f3cd0b82b06560962' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Obstructive sleep apnea (OSA), frequently associated with disruptive snoring, is a prevalent disorder which is increasingly recognized by health care providers and lay people alike as an important factor in impaired daytime executive function as well as cardiovascular disease risk. Along with an increase in its recognition and diagnosis have come a growing pool of patients with milder disease and the associated challenge of ideal management. Positive airway pressure (PAP) is well established as the mainstay of treatment for OSA since it is effective at reversing daytime neurocognitive sequelae and may be a useful adjunct to therapy in those with cardiovascular disease coexisting with OSA. In patients with mild OSA, however, the response to PAP therapy appears muted, which is related in part to poor adherence to treatment. In response, a number of alternative treatments have evolved. The most recent innovation is soft palatal implants, which, in non-randomized, uncontrolled studies have demonstrated reasonable efficacy in the treatment of snoring and mild to moderate OSA. How the implants compare with standard therapy and their effect on cardiovascular variables are unknown. Because of the ease and rapidity with which this system is implanted, and because treatment effect is independent of patient compliance, there is high potential for widespread use in patients with milder OSA. We therefore are conducting a randomized, placebo-controlled clinical trial to compare the impact of palatal implants with PAP on sleep disordered breathing, daytime symptoms and blood pressure, as well as patient / bed partner acceptance.</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:8165654f0586c53f3cd0b82b06560962' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:13f3a2c5083e0248299eb7e281c23930' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>INCLUSION CRITERIA\n<ol>\n<li>Age &gt;18 yrs</li>\n<li>AHI 5-30</li>\n<li>Tonsil size &lt;50% of airway</li>\n<li>No anatomically fixed nasal stenosis</li>\n<li>BMI = 32 kg/m2 EXCLUSION CRITERIA</li>\n</ol>\n</p><p> 1. The presence of a concomitant untreated primary sleep disorder (restless legs syndrome, narcolepsy, idiopathic hypersomnia) 2. Severe daytime sleepiness (history of sleep-related motor vehicle or occupational accident) 3. Moderate to severe pulmonary disease (FEV1 &lt;50% pred) 4. Neurologic impairment (h/o CVA, TIA, neuromuscular disease, diaphragmatic paralysis) 5. Significant cardiac disease (LVEF&lt;50%, moderate to severe valvular disease) 6. Uncontrolled hypertension &gt;180/110 7. Renal disease (Scr &gt; 2.5) 8. Allergy to local anesthetics used for implantation procedure. 9. Pregnant or nursing women</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:13f3a2c5083e0248299eb7e281c23930' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Quality of life</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:75bebc02027c771bd63981df6bd6b124' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>ambulatory blood pressure</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:ce0b1391822ce862592cabf08888b7c0' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>sleepiness</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:5e2fe6c1b6f33370fb10fa9cce732510' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>snoring</p>\n', created = 1283939210, expire = 1284025610, headers = '', serialized = 0 WHERE cid = '1:783aa0bc26beae9764008fc4f397be6b' in /persistent/html/includes/cache.inc on line 109.

Study of the Pillar(R) Palatal Implants in Combination With Continuous Positive Airway Pressure (CPAP) Therapy for the Treatment of Obstructive Sleep Apnea (OSA)

Trial phase: 
Phase IV
Recruitment status: 
Terminated

The study will be done for the following purposes:

  • to see if Pillar implants in combination with CPAP treatment can help people with their OSA by decreasing the CPAP pressures
  • to find out if receiving Pillar implants will increase CPAP use

Background information
Trial ID: 
NCT00730041
Other unique IDs: 
845
Official title: 

Randomized Placebo-Controlled Study of the Pillar® Palatal Implant System With CPAP

Detailed description: 

The Pillar® Palatal Implant System is designed to hold the airway open at night, thus avoiding obstruction. While the Pillar procedure can be effective in the treatment of mild to moderate OSA, its effect in combination with CPAP treatment has never been studied. In this study, the treatment of OSA using the Pillar procedure in combination with standard CPAP treatment vs. sham procedure in combination with standard CPAP treatment will be investigated. All subjects will be asked to continue their normal use of CPAP treatment during the study.

Number to be enrolled: 
52 patients
Acronym: 
Pillar CPAP

Study to Evaluate the Use of Polyethylene Terepthalate (PET) Implants for the Treatment of External Nasal Valve Collapse (NVC)

Trial phase: 
Phase I
Recruitment status: 
Recruiting

The purpose of this study is to research a new implant for the treatment of external nasal valve collapse (NVC). NVC is a condition which causes narrowness and weakness in the nostril which results in nasal obstruction. Implants will be placed in the affected nostril(s). The implants are intended to restore the shape and stabilize the nasal wall to prevent nasal valve collapse and improve the symptoms associated with nasal obstruction.

Background information
Trial ID: 
NCT00729781
Other unique IDs: 
925
Official title: 

Open Label, Baseline Controlled Study to Evaluate the Use of Polyethylene Terepthalate (PET) Implants for the Treatment of External Nasal Valve Collapse and Cosmetic Contour Deformity

Detailed description: 

This study is designed to evaluate a new polyethylene terepthalate implant for the treatment of uni-lateral and bilateral external nasal valve collapse and cosmetic contour deformity. The focus of this investigation will be to specifically address the lateral components of nasal valve collapse caused by weakened, distorted, or absent mechanical strength of the nasal cartilages or their fibrous attachments within the lateral nasal sidewall and nasal ala.

Number to be enrolled: 
72 patients
Acronym: 
NVC

Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea

Trial phase: 
Phase IV
Recruitment status: 
Completed

The Pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe. The implants are placed into the soft area in the roof of the mouth providing support to the soft palate. This research is being done to compare daytime sleepiness and sleep related quality of life after palatal implants.

Background information
Trial ID: 
NCT00307957
Other unique IDs: 
05-08-14-1
Official title: 

Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea

Detailed description: 

Patients will be enrolled into the study based on sleep study results, a physical exam and inclusion/exclusion criteria. Once enrolled, patients are randomized into either the Pillar palatal implant group or a placebo/sham group. In both cases, patients come into the office for placement of the implants. This is an outpatient procedure. Patients are followed at one week, one month and 3 months. At each follow-up visit, patients will undergo a physical exam and complete questionnaires related to sleep and quality of life.

Number to be enrolled: 
100 patients

Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea

Recruitment status: 
Active, not recruiting

The purpose of the study is to compare the effectiveness of soft palatal implants with placebo and continuous positive airway pressure treatment in obstructive sleep apnea.

Background information
Trial ID: 
NCT00263770
Other unique IDs: 
1646-05
5591559902
Official title: 

A Randomized, Controlled Treatment Trial of Soft Palatal Implants and Positive Airway Pressure in Mild to Moderate Obstructive Sleep Apnea and Snoring

Detailed description: 

Obstructive sleep apnea (OSA), frequently associated with disruptive snoring, is a prevalent disorder which is increasingly recognized by health care providers and lay people alike as an important factor in impaired daytime executive function as well as cardiovascular disease risk. Along with an increase in its recognition and diagnosis have come a growing pool of patients with milder disease and the associated challenge of ideal management.

Number to be enrolled: 
84 patients
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