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

August 12, 2007
December 18, 2012
August 2007
August 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00515580 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obstructive Sleep Apnea
  • Upper Airway Resistance Syndrome
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
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.
Intervention: Procedure: Tongue Sutures for Obstructive Sleep Apnea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
August 2009
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00515580
NYEEI IRB 07.20
No
Steven Y. Park M.D., West Side ENT
West Side ENT
Not Provided
Principal Investigator: Steven Y. Park, MD West Side ENT, PLLC
West Side ENT
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP