Minimally Invasive Tongue Suture For Obstructive Sleep Apnea

NCT ID: NCT00515580

Last Updated: 2012-12-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-08-31

Brief Summary

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

Detailed 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.

Conditions

Obstructive Sleep Apnea; Upper Airway Resistance Syndrome

Keywords

obstructive sleep apnea; upper airway resistance syndrome; tongue suture; retrolingual tongue collapse; minimally invasive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tongue Sutures for Obstructive Sleep Apnea

Intervention Type: PROCEDURE

Mandibular osteotomy with placement of Silhouette sutures for genioglossus advancement and hyoid suspension.

Interventions

Tongue Sutures for Obstructive Sleep Apnea

Mandibular osteotomy with placement of Silhouette sutures for genioglossus advancement and hyoid suspension.

Intervention Type: PROCEDURE

Other Intervention Names

tongue suture; mandibular osteotomy and genioglossus advancement; hyoid myotomy and suspension; uvulopalatopharyngoplasty (UPPP); obstructive sleep apnea

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Side ENT

OTHER

Sponsor Role: lead

Responsible Party

Steven Y. Park M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Y. Park, MD

Role: PRINCIPAL_INVESTIGATOR

West Side ENT, PLLC

Locations

330 West 58th Street, Suite 610

New York, New York, United States

West Side ENT

New York, New York, United States

Countries

United States

Other Identifiers

NYEEI IRB 07.20

Identifier Type: -

Identifier Source: org_study_id