FAST as a Treatment for Obstructive Sleep Apnea (FAST)
|Obstructive Sleep Apnea||Device: Encore Tongue Suspension System||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea|
- Place the Implant and Stabilize the Tongue [ Time Frame: Up to 7 weeks after the procedure ]Ability to place the implant and stabilize the tongue
- Number of Participants Experiencing Complications [ Time Frame: 3 months ]Patient will be examined by the investigator at each of the follow-up visits for the presence of any untoward or unintended response to the device.
- Apnea Hypopnea Index [ Time Frame: Baseline, 3, and 12 months ]0 to >30/hour (high value represents worse outcome)
- Functional Outcomes and Sleep Questionnaire (FOSQ) [ Time Frame: Baseline, 1, 3, 12 months ]Questionnaire: 0 to 120 (high value represents better outcome)
- Snoring Scale (VAS) [ Time Frame: Baseline, 1 week; 1 month, 3 months, 12 months ]0 to 10 (high value represents worse outcome)
- Epworth Sleeping Scale (ESS) [ Time Frame: Baseline, 1, 3, 12 months ]0 to 24 (high value represents worse outcome)
|Study Start Date:||May 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Tongue suspension
Device: Encore Tongue Suspension System
The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Obstructive sleep apnea (OSA) has become a major health problem in the United States. With prevalence in middle-aged adults of 2-4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure.
The first and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment, utilized by an estimated 3 million Americans. CPAP is effective in reducing apnea-hypopnea index (AHI) is used properly. However, the nasal mask required for CPAP during sleep leads to poor acceptance and compliance rates. Published studies on CPAP have shown that only 58-8-% of patient accept CPAP therapy and further 65-90% of these patients exhibit long-term compliance with CPAP.
It is widely accepted that the region behind the tongue is a major site of collapse during obstructive sleep apnea. In fact there are many surgical procedures performed currently to address tongue based collapse. These include RF ablation of the tongue base, genioglossus advancement, hyoid suspension, maxillomandibular advancement, and tongue base suspension.
The current study is designed to evaluate the feasibility of tongue stabilization, and assess safety and treatment of the tongue stabilization.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611779
|United States, Georgia|
|The Atlanta Snoring and Sleep Disorders Institute|
|Atlanta, Georgia, United States, 30342|
|Study Director:||Andrew Goldberg, MD||University of California, San Francisco|