Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)

Somnetics

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Somnetics Transcend Auto; Device: Respironics REMstar Auto with C-Flex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01799265

800383

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Transcend followed by REMstar

Active Comparator group

Description:

The patient will receive treatment with Transcend during the first night sleep study, followed by treatment with the REMstar on the second night.

Treatment:

Device: Respironics REMstar Auto with C-Flex

Device: Somnetics Transcend Auto

REMstar followed by Transcend

Active Comparator group

Description:

The patient will receive treatment with REMstar during the first night sleep study followed by treatment with Transcend on the second night.

Treatment:

Device: Respironics REMstar Auto with C-Flex

Device: Somnetics Transcend Auto