Phase 3
Completed N=126
Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
Source: ClinicalTrials.gov NCT01161420 ↗Enrolled (actual)
126
Serious AEs
10.3%
Results posted
Dec 2014
Primary outcomePrimary: Apnea Hypopnea Index — 66 percentage of subjects responding
Summary
The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of the hypoglossal nerve. Study objectives include demonstrating that the Inspire system improves key indices of sleep apnea in a pre-specified percentage of patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index |
66 | — |
| PRIMARY Oxygen Desaturation Index |
75 | — |
| PRIMARY Safety |
494 | — |
| SECONDARY AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study |
12.0; 16.4 | — |
| SECONDARY Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects |
83 | — |
| SECONDARY Change in FOSQ From Baseline to 12 Months |
2.9 | — |
| SECONDARY Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months |
4.7 | — |
| SECONDARY Percentage Sleep Time at SaO2 < 90% |
2.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01161420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.