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Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea

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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

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: soft palate implant Other: Positive airway pressure (PAP) Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. apnea-hypopnea index [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. sleepiness [ Time Frame: 90 days ]
  2. quality of life [ Time Frame: 90 days ]
  3. ambulatory blood pressure [ Time Frame: 90 days ]
  4. snoring [ Time Frame: 90 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sean M Caples, D.O, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00263770     History of Changes
Other Study ID Numbers: 1646-05
5591559902
First Posted: December 9, 2005    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: May 2011

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 Wake Disorders
Nervous System Diseases