FAST as a Treatment for Obstructive Sleep Apnea

NCT ID: NCT01611779

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-06-30

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tongue suspension

Tongue-based suspension

Group Type: EXPERIMENTAL

Encore Tongue Suspension System

Intervention Type: DEVICE

The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.

Interventions

Encore Tongue Suspension System

The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.

Intervention Type: DEVICE

Other Intervention Names

Tongue suspension; FG0002

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siesta Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Goldberg, MD

Role: STUDY_DIRECTOR

University of California, San Francisco

Locations

The Atlanta Snoring and Sleep Disorders Institute

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

2011

Identifier Type: -

Identifier Source: org_study_id