We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01161420
First Posted: July 13, 2010
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Inspire Medical Systems, Inc.
Results First Submitted: May 27, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Obstructive Sleep Apnea
Intervention: Device: Inspire Upper Airway Stimulation System

  Participant Flow
  Hide Participant Flow

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 A total of 803 subjects were withdrawn from the study as they were not eligible and did not receive an implant.126 subjects from 22 clinical sites were implanted the UAS system (3 clinical sites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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[Units: Participants]
 126 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.5  (10.2) 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      110  87.3% 
>=65 years      16  12.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      21  16.7% 
Male      105  83.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   0.8% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      122  96.8% 
More than one race      0   0.0% 
Unknown or Not Reported      3   2.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   0.8% 
Not Hispanic or Latino      2   1.6% 
Unknown or Not Reported      123  97.6% 
Region of Enrollment 
[Units: Participants]
 
France   2 
United States   87 
Belgium   4 
Netherlands   22 
Germany   11 


  Outcome Measures
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Inspire Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01161420     History of Changes
Other Study ID Numbers: Inspire 4
First Submitted: July 9, 2010
First Posted: July 13, 2010
Results First Submitted: May 27, 2014
Results First Posted: December 15, 2014
Last Update Posted: August 25, 2017