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

May 29, 2012
June 4, 2012
May 2012
August 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01611779 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
FAST as a Treatment for Obstructive Sleep Apnea
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).

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.

Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea
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
Experimental: Tongue suspension
Tongue-based suspension
Intervention: Device: Encore Tongue Suspension System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
August 2013
August 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
United States
 
NCT01611779
2011
No
Siesta Medical, Inc.
Siesta Medical, Inc.
Not Provided
Study Director: Andrew Goldberg, MD University of California, San Francisco
Siesta Medical, Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP