Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea |
Device: Inspire Upper Airway Stimulator |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea |
- Apnea Hypopnea Index [ Time Frame: Twelve months ] [ Designated as safety issue: No ]Apnea hypopnea index with therapy at twelve months versus that pre-therapy
- Oxygen Desaturation Index [ Time Frame: Twelve months ] [ Designated as safety issue: No ]Oxygen desaturation index with therapy at 12 months versus that pre-therapy
- Safety [ Time Frame: Twelve months ] [ Designated as safety issue: Yes ]Description of all adverse events
- Sleep related quality of life [ Time Frame: Twelve months ] [ Designated as safety issue: No ]Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire values at twelve months versus those pre-therapy
- Long-term efficacy [ Time Frame: Long-term ] [ Designated as safety issue: No ]Change in sleep study paramaters including when therapy is turned off
- Sleep Architecture Changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]Analysis of sleep architecture variables (e.g., SaO2) at the 12-month follow-up
| Enrollment: | 900 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Inspire Therapy |
Device: 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.
|
| No Intervention: Control |
Detailed Description:
OSA is characterized by recurrent episodes of airflow obstruction in the upper airway that results in oxygen desaturations and arousals from sleep. The most common symptom of OSA is excessive daytime sleepiness. Recent studies have also shown clear association of OSA with the development of obesity, hypertension, diabetes mellitus, and congestive heart failure.
Of those who are treated with CPAP, less than half remain effectively treated due to poor compliance, ineffective patient selection or inadequate therapeutic effect. Surgical procedures of the upper airway such as uvulopalatopharyngoplasty (UPPP) or tongue-based procedures have also met with equivocal results. The upper airway stimulation (UAS) therapy being evaluated in this trial may be a better alternative for treating airway obstructions involving the base of the tongue.
All enrolled subjects will participate in pre-implant testing to verify eligibility for implant. Following pre-implant testing, qualified subjects will undergo a surgical procedure to implant the Inspire system. Following implant, subjects will have scheduled follow-up visits, with data through 12 months serving as the primary endpoint.
Eligibility| Ages Eligible for Study: | 22 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 25 Study Locations| Study Director: | Quan Ni, Ph.D. | Inspire Medical Systems, Inc. |
More Information
Additional Information:
No publications provided
| 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 |
| Last Updated: | April 5, 2012 |
| 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) |
Keywords provided by Inspire Medical Systems, Inc.:
|
tongue surgery neurostimulation hypoglossal nerve upper airway stimulation |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013