Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Inspire Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01161420
First received: July 9, 2010
Last updated: December 11, 2014
Last verified: December 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Obstructive Sleep Apnea
Intervention: Device: Inspire Upper Airway Stimulation 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
Between 10 Nov 2010 and 15 Feb 2012, 25 clinical sites enrolled 929 subjects into the study. A total of 803 subjects were withdrawn from the study as they were not eligible and did not receive an implant.126 subjects from 22 clinical sites were implanted the UAS system (3 clinical sites enrolled subjects but did not attempt or implant a device).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
126 subjects were implanted with the Inspire therapy. At 12 months, the first 46 therapy responders were randomized 1:1 to either therapy ON (maintenance) or therapy OFF (withdrawal) for one week. Those who were in the withdrawal group returned to full therapy after one week of therapy being turned off.

Reporting Groups
  Description
Inspire Therapy 126 subjects were implanted with Inspire therapy

Participant Flow for 3 periods

Period 1:   Inspire Therapy
    Inspire Therapy  
STARTED     126  
COMPLETED     124  
NOT COMPLETED     2  

Period 2:   Withdrawal Study - Maintenance
    Inspire Therapy  
STARTED     23  
COMPLETED     23  
NOT COMPLETED     0  

Period 3:   Withdrawal Study - Withdrawal
    Inspire Therapy  
STARTED     23  
COMPLETED     23  
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.
Sample size was estimated using SAS V9.2 software using the two-sided, two-sample t-test for normal population.

Reporting Groups
  Description
Inspire Therapy

Study subjects continue to use Inspire therapy

Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.


Baseline Measures
    Inspire Therapy  
Number of Participants  
[units: participants]
  126  
Age  
[units: years]
Mean (Standard Deviation)
  54.5  (10.2)  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     110  
>=65 years     16  
Gender  
[units: participants]
 
Female     21  
Male     105  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     122  
More than one race     0  
Unknown or Not Reported     3  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     2  
Unknown or Not Reported     123  
Region of Enrollment  
[units: participants]
 
France     2  
United States     87  
Belgium     4  
Netherlands     22  
Germany     11  



  Outcome Measures
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1.  Primary:   Apnea Hypopnea Index   [ Time Frame: 12 months ]

2.  Primary:   Oxygen Desaturation Index   [ Time Frame: 12 months ]

3.  Primary:   Safety   [ Time Frame: 12 months ]

4.  Secondary:   AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study   [ Time Frame: 12 Months ]

5.  Secondary:   Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects   [ Time Frame: 12 months ]

6.  Secondary:   Change in FOSQ From Baseline to 12 Months   [ Time Frame: Baseline and 12 months ]

7.  Secondary:   Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months   [ Time Frame: Baseline and 12 months ]

8.  Secondary:   Percentage Sleep Time at SaO2 < 90%   [ Time Frame: 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: Quan Ni
Organization: Inspire Medical Systems
phone: 763-205-7968
e-mail: quanni@inspiresleep.com


No publications provided by Inspire Medical Systems, Inc.

Publications automatically indexed to this study:

Responsible Party: Inspire Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01161420     History of Changes
Other Study ID Numbers: Inspire 4
Study First Received: July 9, 2010
Results First Received: May 27, 2014
Last Updated: December 11, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
United States: Food and Drug Administration
Germany: German Institute of Medical Documentation and Information
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)