Minimally Invasive Tongue Suture For Obstructive Sleep Apnea

This study has been terminated.
(Results from first few subjects was not significantly improved over standard, traditional procedures.)
Sponsor:
Information provided by (Responsible Party):
Steven Y. Park M.D., West Side ENT
ClinicalTrials.gov Identifier:
NCT00515580
First received: August 12, 2007
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention
Obstructive Sleep Apnea
Upper Airway Resistance Syndrome
Procedure: Tongue Sutures for Obstructive Sleep Apnea

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Minimally Invasive Genioglossus And Hyoid Advancement For Obstructive Sleep Apnea Using Silhouette Sutures: A Pilot Study

Resource links provided by NLM:


Further study details as provided by West Side ENT:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: August 2007
Study Completion Date: August 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515580

Locations
United States, New York
330 West 58th Street, Suite 610
New York, New York, United States, 10019
West Side ENT
New York, New York, United States, 10019
Sponsors and Collaborators
West Side ENT
Investigators
Principal Investigator: Steven Y. Park, MD West Side ENT, PLLC
  More Information

No publications provided

Responsible Party: Steven Y. Park M.D., Principal Investigator, West Side ENT
ClinicalTrials.gov Identifier: NCT00515580     History of Changes
Other Study ID Numbers: NYEEI IRB 07.20
Study First Received: August 12, 2007
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by West Side ENT:
obstructive sleep apnea
upper airway resistance syndrome
tongue suture
retrolingual tongue collapse
minimally invasive

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders
Sleep Disorders, Intrinsic
Syndrome
Disease
Dyssomnias
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on October 29, 2014