FAST as a Treatment for Obstructive Sleep Apnea

Siesta Medical

Status and phase

Terminated

Phase 4

Conditions

Obstructive Sleep Apnea

Treatments

Device: Encore Tongue Suspension System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01611779

2011

Details and patient eligibility

About

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).

Full 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.

Enrollment

5 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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