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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01161420 |
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Date of registration:
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09/07/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
STAR |
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Scientific title:
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Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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929 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01161420 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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France
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Germany
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Netherlands
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United States
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Contacts
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Name:
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Quan Ni, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inspire Medical Systems, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Likely suffer moderate-to-severe OSA based on history and physical
- Have failed or have not tolerated CPAP treatment
- Willing and capable of providing informed consent
- Willing and capable to have stimulation hardware permanently implanted, and to use the
patient programmer to activate the stimulation
- Willing and capable to return for all follow-up visits and sleep studies, including
the evaluation procedures and filling out the questionnaires
Exclusion Criteria:
- Body Mass Index limits
- Surgical resection or radiation therapy for cancer or congenital malformations in the
larynx, tongue, or throat
- Significant co-morbidities making the patient unable or inappropriate to participate
in the trial
Age minimum:
22 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obstructive Sleep Apnea
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Intervention(s)
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Device: Inspire Upper Airway Stimulation System
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Primary Outcome(s)
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Safety
[Time Frame: 12 months]
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Apnea Hypopnea Index
[Time Frame: 12 months]
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Oxygen Desaturation Index
[Time Frame: 12 months]
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Secondary Outcome(s)
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AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study
[Time Frame: 12 Months]
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Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects
[Time Frame: 12 months]
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Percentage Sleep Time at SaO2 < 90%
[Time Frame: 12 months]
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Change in FOSQ From Baseline to 12 Months
[Time Frame: Baseline and 12 months]
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Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months
[Time Frame: Baseline and 12 months]
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Secondary ID(s)
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Inspire 4
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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