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Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00263770
Recruitment Status : Completed
First Posted : December 9, 2005
Last Update Posted : May 20, 2011
Sponsor:
Collaborators:
Medtronic Xomed, Inc.
ResMed Foundation
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE December 7, 2005
First Posted Date  ICMJE December 9, 2005
Last Update Posted Date May 20, 2011
Study Start Date  ICMJE December 2005
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2011)
apnea-hypopnea index [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2005)
apnea-hypopnea index
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2011)
  • sleepiness [ Time Frame: 90 days ]
  • quality of life [ Time Frame: 90 days ]
  • ambulatory blood pressure [ Time Frame: 90 days ]
  • snoring [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2005)
  • sleepiness
  • quality of life
  • ambulatory blood pressure
  • snoring
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea
Official Title  ICMJE A Randomized, Controlled Treatment Trial of Soft Palatal Implants and Positive Airway Pressure in Mild to Moderate Obstructive Sleep Apnea and Snoring
Brief Summary The purpose of the study is to compare the effectiveness of soft palatal implants with placebo and continuous positive airway pressure treatment in obstructive sleep apnea.
Detailed Description Obstructive sleep apnea (OSA), frequently associated with disruptive snoring, is a prevalent disorder which is increasingly recognized by health care providers and lay people alike as an important factor in impaired daytime executive function as well as cardiovascular disease risk. Along with an increase in its recognition and diagnosis have come a growing pool of patients with milder disease and the associated challenge of ideal management. Positive airway pressure (PAP) is well established as the mainstay of treatment for OSA since it is effective at reversing daytime neurocognitive sequelae and may be a useful adjunct to therapy in those with cardiovascular disease coexisting with OSA. In patients with mild OSA, however, the response to PAP therapy appears muted, which is related in part to poor adherence to treatment. In response, a number of alternative treatments have evolved. The most recent innovation is soft palatal implants, which, in non-randomized, uncontrolled studies have demonstrated reasonable efficacy in the treatment of snoring and mild to moderate OSA. How the implants compare with standard therapy and their effect on cardiovascular variables are unknown. Because of the ease and rapidity with which this system is implanted, and because treatment effect is independent of patient compliance, there is high potential for widespread use in patients with milder OSA. We therefore are conducting a randomized, placebo-controlled clinical trial to compare the impact of palatal implants with PAP on sleep disordered breathing, daytime symptoms and blood pressure, as well as patient / bed partner acceptance.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Sleep Apnea, Obstructive
Intervention  ICMJE
  • Device: soft palate implant
  • Other: Positive airway pressure (PAP)
    which is air delivered by a mask worn over the nose during sleep
Study Arms  ICMJE
  • Positive airway pressure (PAP)
    which is air delivered by a mask worn over the nose during sleep
    Intervention: Other: Positive airway pressure (PAP)
  • Active Comparator: outpatient surgical procedure
    where small fabric rods are inserted into the soft palate (the fleshy portion of the roof of the mouth) to stiffen the tissues.
    Intervention: Device: soft palate implant
  • Sham Comparator: Sham surgery
    an outpatient surgical procedure identical to #2 except that no rods are inserted into the soft palate.
    Intervention: Device: soft palate implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2011)
64
Original Enrollment  ICMJE
 (submitted: December 7, 2005)
84
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA

  1. Age >18 yrs
  2. AHI 5-30
  3. Tonsil size <50% of airway
  4. No anatomically fixed nasal stenosis
  5. BMI = 32 kg/m2 EXCLUSION CRITERIA

1. The presence of a concomitant untreated primary sleep disorder (restless legs syndrome, narcolepsy, idiopathic hypersomnia) 2. Severe daytime sleepiness (history of sleep-related motor vehicle or occupational accident) 3. Moderate to severe pulmonary disease (FEV1 <50% pred) 4. Neurologic impairment (h/o CVA, TIA, neuromuscular disease, diaphragmatic paralysis) 5. Significant cardiac disease (LVEF<50%, moderate to severe valvular disease) 6. Uncontrolled hypertension >180/110 7. Renal disease (Scr > 2.5) 8. Allergy to local anesthetics used for implantation procedure. 9. Pregnant or nursing women

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00263770
Other Study ID Numbers  ICMJE 1646-05
5591559902
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sean M Caples, D.O, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE
  • Medtronic Xomed, Inc.
  • ResMed Foundation
Investigators  ICMJE
Principal Investigator: Sean M. Caples, D.O. Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2011

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