FAST as a Treatment for Obstructive Sleep Apnea
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea |
Device: Encore Tongue Suspension System |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea |
- Ability to place the implant and stabilize the tongue [ Time Frame: Up to 7 weeks after the procedure ] [ Designated as safety issue: No ]Ability to place the implant and stibilize the tongue
- Complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Evaluate safety of the device
- Apnea hypopnea index [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]0 to >30/hour (high value represents worse outcome)
- Functional Outcomes and Sleep Questionnaire (FOSQ) [ Time Frame: 1, 3, 12 month ] [ Designated as safety issue: No ]0 to 120 (high value represents better outcome)
- Snoring Scale (VAS) [ Time Frame: 1 week; 1, 3, 12 months ] [ Designated as safety issue: Yes ]0 to 10 (high value represents worse outcome)
- Epworth Sleeping Scale (ESS) [ Time Frame: 1, 3, 12 months ] [ Designated as safety issue: No ]0 to 24 (high value represents worse outcome)
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tongue suspension
Tongue-based 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.
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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/m2)
- 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
Exclusion Criteria:
- 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
Contacts and Locations| United States, Georgia | |
| The Atlanta Snoring and Sleep Disorders Institute | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Samuel Mickelson, MD 404-943-0900 | |
| Study Director: | Andrew Goldberg, MD | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | Siesta Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01611779 History of Changes |
| Other Study ID Numbers: | 2011 |
| Study First Received: | May 29, 2012 |
| Last Updated: | June 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Siesta Medical, Inc.:
|
obstructive sleep apnea tongue suspension |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013