Minimally Invasive Tongue Suture For Obstructive Sleep Apnea

NCT00515580 | Terminated

• 1 other identifier: NYEEI IRB 07.20
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea; Upper Airway Resistance Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Procedure: Tongue Sutures for Obstructive Sleep Apnea

Interventions

Tongue Sutures for Obstructive Sleep Apnea PROCEDURE

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

Also known as: tongue suture, mandibular osteotomy and genioglossus advancement, hyoid myotomy and suspension, uvulopalatopharyngoplasty (UPPP), obstructive sleep apnea

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Side ENT: lead

Study Sites (2)

330 West 58th Street, Suite 610

New York, New York, 10019, United States

Location

West Side ENT

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Mandibular Osteotomy; Suspensions

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthognathic Surgical Procedures; Oral Surgical Procedures; Dentistry; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Steven Y. Park, MD

  West Side ENT, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2007
• First Posted: August 14, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2009
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

US (2)