FAST as a Treatment for Obstructive Sleep Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Siesta Medical, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Siesta Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01611779
First received: May 29, 2012
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention Phase
Obstructive Sleep Apnea
Device: Encore Tongue Suspension System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Siesta Medical, Inc.:

Primary Outcome Measures:
  • Ability to place the implant and stabilize the tongue [ Time Frame: Up to 7 weeks after the procedure ] [ Designated as safety issue: No ]
    Ability to place the implant and stibilize the tongue

  • Complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Evaluate safety of the device


Secondary Outcome Measures:
  • Apnea hypopnea index [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    0 to >30/hour (high value represents worse outcome)

  • Functional Outcomes and Sleep Questionnaire (FOSQ) [ Time Frame: 1, 3, 12 month ] [ Designated as safety issue: No ]
    0 to 120 (high value represents better outcome)

  • Snoring Scale (VAS) [ Time Frame: 1 week; 1, 3, 12 months ] [ Designated as safety issue: Yes ]
    0 to 10 (high value represents worse outcome)

  • Epworth Sleeping Scale (ESS) [ Time Frame: 1, 3, 12 months ] [ Designated as safety issue: No ]
    0 to 24 (high value represents worse outcome)


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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/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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611779

Locations
United States, Georgia
The Atlanta Snoring and Sleep Disorders Institute Recruiting
Atlanta, Georgia, United States, 30342
Contact: Samuel Mickelson, MD    404-943-0900      
Sponsors and Collaborators
Siesta Medical, Inc.
Investigators
Study Director: Andrew Goldberg, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Siesta Medical, Inc.
ClinicalTrials.gov Identifier: NCT01611779     History of Changes
Other Study ID Numbers: 2011
Study First Received: May 29, 2012
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Siesta Medical, Inc.:
obstructive sleep apnea
tongue suspension

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014