Brief Summary

Skip to Participation Criteria

Official Title: "Minimally Invasive Genioglossus And Hyoid Advancement For Obstructive Sleep Apnea Using Silhouette Sutures: A Pilot Study"

This is a pilot study to determine the usefulness of a newly developed, minimally invasive tongue suture procedure for people with obstructive sleep apnea.

• Study Type: Interventional
• Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: August 2008

Detailed Clinical Trial Description

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.

Interventions Used in this Clinical Trial

• Procedure: Tongue Sutures for Obstructive Sleep Apnea
  • Mandibular osteotomy with placement of Silhouette sutures for genioglossus advancement and hyoid suspension.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

• Using standardized validated sleep disordered breathing and quality of life questionnaires (pre-op, 3 months, and 12 months). Patients will undergo a post-operative polysomnogram at 12 months.
  • Time Frame: one year or until 5 patients enrolled and completed
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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:

• men and women ages 18 to 65
• supine Park tongue position 3+ or greater
• tonsil size 2 or less
• Mueller's 2+ or less
• Friedman Stage II/III
• BMI ≤ 30
• AHI ≥ 5

Exclusion Criteria

• Prior pharyngeal surgery
• History of radiation to the head and neck
• Dysmorphic facies or craniofacial syndrome
• ASA class IV or V
• Major depression or unstable psychiatric disorder
• Pregnancy
• Illiteracy (unable to complete required forms)
• No phone # or mailing address, or plans to change in 3 month period
• Any upper airway surgery within three month period

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • West Side ENT
• Provider of Information About this Clinical Study
  • Principal Investigator: Steven Y. Park M.D., Principal Investigator - West Side ENT
• Overall Official(s)
  • Steven Y. Park, MD, Principal Investigator, West Side ENT, PLLC