FAST as a Treatment for Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

— FAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01611779
• Other study ID #: 2011
• Status: Recruiting
• Phase: Phase 4
• First received: May 29, 2012
• Last updated: June 4, 2012
• Start date: May 2012
• Est. completion date: August 2013

Study information

• Verified date: June 2012
• Source: Siesta Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	The Atlanta Snoring and Sleep Disorders Institute	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Siesta Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to place the implant and stabilize the tongue	Ability to place the implant and stibilize the tongue	Up to 7 weeks after the procedure	No
Primary	Complications	Evaluate safety of the device	3 months	Yes
Secondary	Apnea hypopnea index	0 to >30/hour (high value represents worse outcome)	3 and 12 months	No
Secondary	Functional Outcomes and Sleep Questionnaire (FOSQ)	0 to 120 (high value represents better outcome)	1, 3, 12 month	No
Secondary	Snoring Scale (VAS)	0 to 10 (high value represents worse outcome)	1 week; 1, 3, 12 months	Yes
Secondary	Epworth Sleeping Scale (ESS)	0 to 24 (high value represents worse outcome)	1, 3, 12 months	No