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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
Results First Received: November 9, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Obstructive Sleep Apnea
Intervention: Device: Encore Tongue Suspension System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tongue Suspension

Tongue-based suspension

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


Participant Flow:   Overall Study
    Tongue Suspension
STARTED   5 
COMPLETED   5 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients with obstructive sleep apnea were enrolled in the trial. Subjects meeting the inclusion and exclusion criteria were invited to participate in the trial. Subjects were treated with the the Encore System, and followed at 1 week, and then at 1, 3, and 12 months.

Reporting Groups
  Description
Tongue Suspension

Tongue-based suspension

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


Baseline Measures
   Tongue Suspension 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      5 100.0% 
>=65 years      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
 
Female      1  20.0% 
Male      4  80.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1  20.0% 
Not Hispanic or Latino      4  80.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   5 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26.98  (3.78) 
Prior OSA Surgery 
[Units: Participants]
Count of Participants
 5 


  Outcome Measures
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1.  Primary:   Place the Implant and Stabilize the Tongue   [ Time Frame: Up to 7 weeks after the procedure ]

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

3.  Secondary:   Apnea Hypopnea Index   [ Time Frame: Baseline, 3, and 12 months ]

4.  Secondary:   Functional Outcomes and Sleep Questionnaire (FOSQ)   [ Time Frame: Baseline, 1, 3, 12 months ]

5.  Secondary:   Snoring Scale (VAS)   [ Time Frame: Baseline, 1 week; 1 month, 3 months, 12 months ]

6.  Secondary:   Epworth Sleeping Scale (ESS)   [ Time Frame: Baseline, 1, 3, 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael Kolber
Organization: Siesta Medical, Inc.
phone: 408-320-9424
e-mail: mkolber@siestamedical.com



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