FAST as a Treatment for Obstructive Sleep Apnea (FAST)

Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea

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).

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Encore Tongue Suspension System

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • The Atlanta Snoring and Sleep Disorders Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Tongue suspension; FG0002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Place the Implant and Stabilize the Tongue	Ability to place the implant and stabilize the tongue	Up to 7 weeks after the procedure
Number of Participants Experiencing Complications	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea Hypopnea Index	0 to >30/hour (high value represents worse outcome)	Baseline, 3, and 12 months
Functional Outcomes and Sleep Questionnaire (FOSQ)	Questionnaire: 0 to 120 (high value represents better outcome)	Baseline, 1, 3, 12 months
Snoring Scale (VAS)	0 to 10 (high value represents worse outcome)	Baseline, 1 week; 1 month, 3 months, 12 months
Epworth Sleeping Scale (ESS)	0 to 24 (high value represents worse outcome)	Baseline, 1, 3, 12 months

Collaborators and Investigators

• Sponsor: Siesta Medical, Inc.
• Investigators: Study Director: Andrew Goldberg, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 29, 2012
• First Submitted That Met QC Criteria: June 4, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; tongue suspension
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2011 (Registry Identifier: sherin)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No