Minimally Invasive Tongue Suture For Obstructive Sleep Apnea

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 Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea; Upper Airway Resistance Syndrome
• Intervention / Treatment: Procedure: Tongue Sutures for 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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • 330 West 58th Street, Suite 610
    • New York, New York, United States, 10019
      • West Side ENT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Tongue Sutures for Obstructive Sleep Apnea; Mandibular osteotomy with placement of Silhouette sutures for genioglossus advancement and hyoid suspension.; Other Names: tongue suture; mandibular osteotomy and genioglossus advancement; hyoid myotomy and suspension; uvulopalatopharyngoplasty (UPPP); obstructive sleep apnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: West Side ENT
• Investigators: Principal Investigator: Steven Y. Park, MD, West Side ENT, PLLC

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): August 1, 2008
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: August 12, 2007
• First Submitted That Met QC Criteria: August 12, 2007
• First Posted (ESTIMATE): August 14, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 18, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; minimally invasive; upper airway resistance syndrome; tongue suture; retrolingual tongue collapse
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: NYEEI IRB 07.20