Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Other: Positive airway pressure (PAP); Device: soft palate implant

• Registration Number: NCT00263770
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-07
• Study First Submitted QC: 2005-12-07
• Study First Posted: 2005-12-09
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive airway pressure (PAP)	Positive airway pressure (PAP)	which is air delivered by a mask worn over the nose during sleep
outpatient surgical procedure	soft palate implant	where small fabric rods are inserted into the soft palate (the fleshy portion of the roof of the mouth) to stiffen the tissues.
Sham surgery	soft palate implant	an outpatient surgical procedure identical to #2 except that no rods are inserted into the soft palate.

Primary Outcome Measures

Name	Time	Method
apnea-hypopnea index	90 days

Secondary Outcome Measures

Name	Time	Method
sleepiness	90 days
quality of life	90 days
ambulatory blood pressure	90 days
snoring	90 days

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States