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Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea

NCT00263770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2011-05-20

No results posted yet for this study

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.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DEVICE

soft palate implant

OTHER

Positive airway pressure (PAP)

which is air delivered by a mask worn over the nose during sleep

Sponsors & Collaborators

  • Medtronic Xomed, Inc.

    collaborator INDUSTRY

  • ResMed Foundation

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Sean M. Caples, D.O. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00263770 on ClinicalTrials.gov