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

Somnetics International, Inc.41 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Somnetics Transcend AutoDEVICE

Respironics REMstar Auto with C-FlexDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Northwind Lung Specialists and Sleep Center

Coon Rapids, Minnesota, United States

Whitney Sleep Center

Plymouth, Minnesota, United States

Sleep Therapy and Research Center

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Mean Apnea Hypopnea Index (AHI) During Treatment

Apnea hypopnea index (AHI) will be measured during treatment with each of the devices. AHI = (number of apneas + number of hypopneas) / total sleep time in hours. The minimum score is zero. The higher the score, the more severe the sleep apnea. For example, obstructive sleep apnea is defined as an AHI \>/= 15. AHI was measured by the devices and independently by a central laboratory.

Time frame: first and second night sleep study

Secondary Outcomes

Unanticipated Adverse Device Effects

Patients will be monitored for unanticipated adverse device effects during each sleep study. Patients will not be followed after the second sleep study.

Time frame: first and second night sleep study

Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI)

Mean hypopnea index will be measure during treatment. HI will be measured during treatment with each of the devices. HI = number of hypopneas / total sleep time in hours. The minimum score is zero. The higher the score, the more severe the sleep apnea. For example, obstructive sleep apnea is defined as an AHI \>/= 15. HI was measured by the devices and independently by a central laboratory. Results are reported as the Mean Differences between PSG and Device Hypopnea Index. These differences can be reported as negative values.

Time frame: first and second night sleep study

Data from ClinicalTrials.gov

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