Clinical trial NCT01611779: FAST as a Treatment for Obstructive Sleep Apnea
Official title: Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
tongue suspension
Lead sponsor: Siesta Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-05
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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 criteria: 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/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

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

Primary outcomes:
measure: Place the Implant and Stabilize the Tongue
timeFrame: Up to 7 weeks after the procedure
measure: Number of Participants Experiencing Complications
timeFrame: 3 months
Secondary outcomes:
measure: Apnea Hypopnea Index
timeFrame: Baseline, 3, and 12 months
measure: Functional Outcomes and Sleep Questionnaire (FOSQ)
timeFrame: Baseline, 1, 3, 12 months
measure: Snoring Scale (VAS)
timeFrame: Baseline, 1 week; 1 month, 3 months, 12 months
measure: Epworth Sleeping Scale (ESS)
timeFrame: Baseline, 1, 3, 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: The Atlanta Snoring and Sleep Disorders Institute
state: Georgia
Study officials:
affiliation: University of California, San Francisco
name: Andrew Goldberg, MD
role: STUDY_DIRECTOR
References: