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

January 8, 2025 updated by: Somnetics International, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Northwind Lung Specialists and Sleep Center
      • Plymouth, Minnesota, United States, 55441
        • Whitney Sleep Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Sleep Therapy and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transcend followed by REMstar
The patient will receive treatment with Transcend during the first night sleep study, followed by treatment with the REMstar on the second night.
Device: Somnetics Transcend Auto
Device: Respironics REMstar Auto with C-Flex
Active Comparator: REMstar followed by Transcend
The patient will receive treatment with REMstar during the first night sleep study followed by treatment with Transcend on the second night.
Device: Somnetics Transcend Auto
Device: Respironics REMstar Auto with C-Flex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Apnea Hypopnea Index (AHI) During Treatment
Time Frame: first and second night sleep study
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.
first and second night sleep study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unanticipated Adverse Device Effects
Time Frame: first and second night sleep study
Patients will be monitored for unanticipated adverse device effects during each sleep study. Patients will not be followed after the second sleep study.
first and second night sleep study
Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI)
Time Frame: first and second night sleep study
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.
first and second night sleep study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somnetics International, Inc.

Investigators

  • Principal Investigator: Eric Powell, PhD RPSGT, Sleep Therapy and Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 27, 2013

Primary Completion (Actual)

June 10, 2013

Study Completion (Actual)

June 10, 2013

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 25, 2013

First Posted (Estimated)

February 26, 2013

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 800383

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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