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FAST as a Treatment for Obstructive Sleep Apnea (FAST)

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Siesta Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01611779
First received: May 29, 2012
Last updated: January 10, 2017
Last verified: January 2017
  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: 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:
  • Place the Implant and Stabilize the Tongue [ Time Frame: Up to 7 weeks after the procedure ]
    Ability to place the implant and stabilize the tongue

  • Number of Participants Experiencing Complications [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures:
  • Apnea Hypopnea Index [ Time Frame: Baseline, 3, and 12 months ]
    0 to >30/hour (high value represents worse outcome)

  • Functional Outcomes and Sleep Questionnaire (FOSQ) [ Time Frame: Baseline, 1, 3, 12 months ]
    Questionnaire: 0 to 120 (high value represents better outcome)

  • Snoring Scale (VAS) [ Time Frame: Baseline, 1 week; 1 month, 3 months, 12 months ]
    0 to 10 (high value represents worse outcome)

  • Epworth Sleeping Scale (ESS) [ Time Frame: Baseline, 1, 3, 12 months ]
    0 to 24 (high value represents worse outcome)


Enrollment: 5
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (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   (Adult)
Sexes Eligible for Study:   All
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/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
  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
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Siesta Medical, Inc.
Investigators
Study Director: Andrew Goldberg, MD University of California, San Francisco
  More Information

Responsible Party: Siesta Medical, Inc.
ClinicalTrials.gov Identifier: NCT01611779     History of Changes
Other Study ID Numbers: 2011
Study First Received: May 29, 2012
Results First Received: November 9, 2016
Last Updated: January 10, 2017
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on June 26, 2017