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Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Collaborators:
Medtronic Xomed, Inc.
ResMed Foundation
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00263770
First received: December 7, 2005
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Sleep Apnea, Obstructive
Device: soft palate implant
Other: Positive airway pressure (PAP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Treatment Trial of Soft Palatal Implants and Positive Airway Pressure in Mild to Moderate Obstructive Sleep Apnea and Snoring

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • apnea-hypopnea index [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sleepiness [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • ambulatory blood pressure [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • snoring [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: December 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Positive airway pressure (PAP)
which is air delivered by a mask worn over the nose during sleep
Other: Positive airway pressure (PAP)
which is air delivered by a mask worn over the nose during sleep
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.
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.
Device: soft palate implant

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  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: NCT00263770

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Medtronic Xomed, Inc.
ResMed Foundation
Investigators
Principal Investigator: Sean M. Caples, D.O. Mayo Clinic
  More Information

No publications provided

Responsible Party: Sean M Caples, D.O, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00263770     History of Changes
Other Study ID Numbers: 1646-05, 5591559902
Study First Received: December 7, 2005
Last Updated: May 18, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014