Back to resultsFAST as a Treatment for Obstructive Sleep Apnea (FAST)
Primary Purpose
Obstructive Sleep Apnea
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Encore Tongue Suspension System
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, tongue suspension
Eligibility 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
Sites / Locations
- The Atlanta Snoring and Sleep Disorders Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tongue suspension
Arm Description
Tongue-based suspension
Outcomes
Primary Outcome Measures
Place the Implant and Stabilize the Tongue
Ability to place the implant and stabilize the tongue
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.
Secondary Outcome Measures
Apnea Hypopnea Index
0 to >30/hour (high value represents worse outcome)
Functional Outcomes and Sleep Questionnaire (FOSQ)
Questionnaire: 0 to 120 (high value represents better outcome)
Snoring Scale (VAS)
0 to 10 (high value represents worse outcome)
Epworth Sleeping Scale (ESS)
0 to 24 (high value represents worse outcome)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01611779
Brief Title
FAST as a Treatment for Obstructive Sleep Apnea
Acronym
FAST
Official Title
Functional Advancement and Suspension of the Tongue (FAST) as a Treatment for Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Siesta Medical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, tongue suspension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tongue suspension
Arm Type
Experimental
Arm Description
Tongue-based suspension
Intervention Type
Device
Intervention Name(s)
Encore Tongue Suspension System
Other Intervention Name(s)
Tongue suspension, FG0002
Intervention Description
The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Primary Outcome Measure Information:
Title
Place the Implant and Stabilize the Tongue
Description
Ability to place the implant and stabilize the tongue
Time Frame
Up to 7 weeks after the procedure
Title
Number of Participants Experiencing Complications
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Apnea Hypopnea Index
Description
0 to >30/hour (high value represents worse outcome)
Time Frame
Baseline, 3, and 12 months
Title
Functional Outcomes and Sleep Questionnaire (FOSQ)
Description
Questionnaire: 0 to 120 (high value represents better outcome)
Time Frame
Baseline, 1, 3, 12 months
Title
Snoring Scale (VAS)
Description
0 to 10 (high value represents worse outcome)
Time Frame
Baseline, 1 week; 1 month, 3 months, 12 months
Title
Epworth Sleeping Scale (ESS)
Description
0 to 24 (high value represents worse outcome)
Time Frame
Baseline, 1, 3, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Goldberg, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Director
Facility Information:
Facility Name
The Atlanta Snoring and Sleep Disorders Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FAST as a Treatment for Obstructive Sleep Apnea
We'll reach out to this number within 24 hrs