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

July 9, 2010
April 5, 2012
July 2010
March 2013   (final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT01161420 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obstructive Sleep Apnea
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.
  • Active Comparator: Inspire Therapy
    Intervention: Device: Inspire Upper Airway Stimulator
  • No Intervention: Control
Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
March 2014
March 2013   (final data collection date for primary outcome measure)

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
Both
22 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   France,   Germany,   Netherlands
 
NCT01161420
Inspire 4
Yes
Inspire Medical Systems, Inc.
Inspire Medical Systems, Inc.
Not Provided
Study Director: Quan Ni, Ph.D. Inspire Medical Systems, Inc.
Inspire Medical Systems, Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP