Minimally Invasive Tongue Suture For Obstructive Sleep Apnea
Stopped early · Not applicable
Conditions studied: Obstructive Sleep Apnea, Upper Airway Resistance Syndrome
In brief
This is a pilot study to determine the usefulness of a newly developed, minimally invasive tongue suture procedure for people with obstructive sleep apnea.
Key facts
- Study ID
- NCT00515580
- Run by
- West Side ENT
- People needed
- 5
- Starts
- 2007-08-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2012-12-20
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 330 West 58th Street, Suite 610 — New York, New York, United States
- West Side ENT — New York, New York, United States
Full record on ClinicalTrials.gov
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