FAST as a Treatment for Obstructive Sleep Apnea
Stopped early · Phase 4
Conditions studied: Obstructive Sleep Apnea
In brief
The objective of this study is to assess the feasibility and safety of tongue suspension using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive sleep apnea (OSA).
Key facts
- Study ID
- NCT01611779
- Run by
- Siesta Medical, Inc.
- People needed
- 5
- Starts
- 2012-05-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2017-02-24
Who can join
Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented diagnosis of moderate obstructive sleep apnea (AHI 5-30/hour) measured within 12 months prior to the planned procedure
- Age >/= 20 and >/= 65
- Body Mass Index ,/= 32 (kg/m\^2)
- Patient offered CPAP and has refused of failed to continue CPAP treatment or is not compliant with CPAP
- Signed informed consent to participate in this study
You may not qualify if…
- Prior OSA surgery
- Active systemic infection
- Allergy to any medication used during implantation
- Previous history of neck or upper respiratory tract
- Significant dysphagia or speech disorder
- Anatomical
- Identified obvious palatal stenosis
- Enlarged tonsils (3+)
- Anatomy unable to accommodate the implant
- Other
- Other medical, social, or psychological problems that , in the opinion of the investigator, precludes the patient from receiving this treatment and the procedures and evaluations pre- and post-treatment
- Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study
- Unable and/or not willing to comply with treatment follow-up requirements
- Pregnancy (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment
Where it is running
- The Atlanta Snoring and Sleep Disorders Institute — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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