Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea

A Randomized, Controlled Treatment Trial of Soft Palatal Implants and Positive Airway Pressure in Mild to Moderate Obstructive Sleep Apnea and Snoring

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Other: Positive airway pressure (PAP); 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
apnea-hypopnea index	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
sleepiness	90 days
quality of life	90 days
ambulatory blood pressure	90 days
snoring	90 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: ResMed Foundation; Medtronic Xomed, Inc.
• Investigators: Principal Investigator: Sean M. Caples, D.O., Mayo Clinic

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: December 7, 2005
• First Submitted That Met QC Criteria: December 7, 2005
• First Posted (Estimate): December 9, 2005

Study Record Updates

• Last Update Posted (Estimate): May 20, 2011
• Last Update Submitted That Met QC Criteria: May 18, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 1646-05; 5591559902