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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Inspire Medical Systems, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Inspire Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01161420
First received: July 9, 2010
Last updated: April 5, 2012
Last verified: April 2012
  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

Resource links provided by NLM:


Further study details as provided by Inspire Medical Systems, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161420

  Show 25 Study Locations
Sponsors and Collaborators
Inspire Medical Systems, Inc.
Investigators
Study Director: Quan Ni, Ph.D. Inspire Medical Systems, Inc.
  More Information

Additional Information:
No publications provided by Inspire Medical Systems, Inc.

Additional 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
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:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014