Minimally Invasive Tongue Suture For Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00515580
• Other study ID #: NYEEI IRB 07.20
• Status: Terminated
• Phase: N/A
• First received: August 12, 2007
• Last updated: December 18, 2012
• Start date: August 2007
• Est. completion date: August 2009

Study information

• Verified date: December 2012
• Source: West Side ENT
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Upper Airway Resistance Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	330 West 58th Street, Suite 610	New York	New York
United States	West Side ENT	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
West Side ENT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		one year or until 5 patients enrolled and completed	No