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Sponsored by: |
West Side ENT |
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Information provided by: | West Side ENT |
ClinicalTrials.gov Identifier: | NCT00515580 |
This is a pilot study to determine the usefulness of a newly developed, minimally invasive tongue suture procedure for people with obstructive sleep apnea.
Condition | Intervention |
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Obstructive Sleep Apnea Upper Airway Resistance Syndrome |
Procedure: Tongue Sutures for Obstructive Sleep Apnea |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Minimally Invasive Genioglossus And Hyoid Advancement For Obstructive Sleep Apnea Using Silhouette Sutures: A Pilot Study |
Estimated Enrollment: | 5 |
Study Start Date: | August 2007 |
Arms | Assigned Interventions |
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A: Experimental
Pilot study of 5 patients, with an additional 20 patients with conditional approval by the IRB once the initial 5 patient's data is reviewed.
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Procedure: Tongue Sutures for Obstructive Sleep Apnea
Mandibular osteotomy with placement of Silhouette sutures for genioglossus advancement and hyoid suspension.
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Obstructive sleep apnea is a common sleep-breathing disorder characterized by repetitive complete cessation of breathing due to pharyngeal obstruction. Untreated, it has been strongly associated with daytime sleepiness, hypertension, depression, coronary artery disease, stroke, and even death. It is estimated that up to 25% of men and 9% of women may suffer from this condition. One proposed mechanism of pharyngeal obstruction is that the posterior tongue is susceptible to collapse when supine during sleep, which causes further collapse of the soft palate and related structures. Treatment includes continuous positive airway pressure (CPAP), mandibular advancement devices, and various surgical options. There are many surgical options for treating tongue base collapse, many of which are morbid with significant pain and discomfort involved. Silhouette Sutures (Kolster Methods, Inc.) are designed to hold and grip soft tissues using intermittently placed dissolvable cones spaced by knots. It has been used widely for years for facial cosmetic procedures with excellent results and safety record. This is a pilot study evaluating the practicality and efficacy of using Silhouette Sutures in an innovative, minimally invasive technique that obviates the need for more aggressive and morbid procedures for obstructive sleep apnea.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Five patients will be recruited during a period of one year, or until a total of five patients have been recruited and have taken part. Patients must have undergone a formal overnight polysomnogram with documented obstructive sleep apnea within the past 2 years with no significant change in their weight or symptoms. They must have tried or refused all available nonsurgical options (CPAP or mandibular advancement devices), and must be ideal candidates for traditional upper airway surgery. Based on the polysomnogram results and specific entry criteria, patients will be recruited. All patients will undergo a full ENT examination and a fiberoptic laryngoscopy, examining the nasal cavity, palatal structures and tongue position, both in the sitting and supine positions (a routine part of the ENT examination).
Entry criteria include the following:
Exclusion Criteria:
Contact: Steven Y. Park, MD | (212) 315-9058 | sypark@mac.com |
United States, New York | |
West Side ENT | Recruiting |
New York, New York, United States, 10019 | |
Contact: Steven Y. Park, MD 212-315-9058 sypark@mac.com | |
Contact: Steven Y. Park, MD (212) 315-9058 sypark@mac.com | |
Principal Investigator: Steven Y. Park, MD |
Principal Investigator: | Steven Y. Park, MD | West Side ENT, PLLC |
Study ID Numbers: | NYEEI IRB 07.20 |
Study First Received: | August 12, 2007 |
Last Updated: | August 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00515580 |
Health Authority: | United States: Institutional Review Board |
obstructive sleep apnea upper airway resistance syndrome tongue suture retrolingual tongue collapse minimally invasive |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Pathologic Processes Disease Syndrome Nervous System Diseases |