Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatments somnetics transcend auto, respironics remstar auto with c-flex
Sponsor Somnetics International, Inc.
Start date February 2013
End date June 2013
Trial size 36 participants
Trial identifier NCT01799265, 800383

Summary

The purpose of this study is to determine whether the Transcend Auto is as effective in treating obstructive sleep apnea as another device that is already on the market.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
The patient will receive treatment with Transcend during the first night sleep study, followed by treatment with the REMstar on the second night.
somnetics transcend auto
respironics remstar auto with c-flex
(Active Comparator)
The patient will receive treatment with REMstar during the first night sleep study followed by treatment with Transcend on the second night.
somnetics transcend auto
respironics remstar auto with c-flex

Primary Outcomes

Measure
Mean apnea hypopnea index during treatment
time frame: first and second night sleep study

Secondary Outcomes

Measure
unanticipated adverse device effects
time frame: first and second night sleep study
Mean apnea index and hypopnea index during treatment
time frame: first and second night sleep study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult 18 years of age or older - Diagnosis of obstructive sleep apnea - Presently using CPAP or APAP therapy Exclusion Criteria: - Central or mixed apnea

Additional Information

Official title Transcend Auto Clinical Evaluation
Principal investigator Eric Powell, PhD RPSGT
Description This is a prospective, randomized, crossover trial. Patients will be randomized 1:1 to undergo two full night sleep studies with the Transcend Auto and a commercially available device.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Somnetics International, Inc..