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Minimally Invasive Tongue Suture For Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00515580
Recruitment Status : Terminated (Results from first few subjects was not significantly improved over standard, traditional procedures.)
First Posted : August 14, 2007
Last Update Posted : December 20, 2012
Information provided by (Responsible Party):
Steven Y. Park M.D., West Side ENT

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Upper Airway Resistance Syndrome Procedure: Tongue Sutures for Obstructive Sleep Apnea Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimally Invasive Genioglossus And Hyoid Advancement For Obstructive Sleep Apnea Using Silhouette Sutures: A Pilot Study
Study Start Date : August 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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

Primary Outcome Measures :
  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. [ Time Frame: one year or until 5 patients enrolled and completed ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00515580

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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
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Principal Investigator: Steven Y. Park, MD West Side ENT, PLLC
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Responsible Party: Steven Y. Park M.D., Principal Investigator, West Side ENT Identifier: NCT00515580    
Other Study ID Numbers: NYEEI IRB 07.20
First Posted: August 14, 2007    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012
Keywords provided by Steven Y. Park M.D., West Side ENT:
obstructive sleep apnea
upper airway resistance syndrome
tongue suture
retrolingual tongue collapse
minimally invasive
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases