Completed

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

What is being tested

Somnetics Transcend Auto

+ Respironics REMstar Auto with C-Flex

+ Somnetics Transcend Auto

Device

Who is being recruted

Apnea+6

+ Nervous System Diseases

+ Respiration Disorders

Over 18 Years

+4 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: February 2013

See protocol details

Summary

Principal SponsorSomnetics International, Inc.

Last updated: January 13, 2025

Sourced from a government-validated database.Claim as a partner

Study start date: February 27, 2013

Actual date on which the first participant was enrolled.

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.

NCT01799265

Principal SponsorSomnetics International, Inc.

Last updated: January 13, 2025

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

41 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasSleep Apnea SyndromesSleep Apnea, Obstructive

Criteria

3 inclusion criteria required to participate

Adult 18 years of age or older

Diagnosis of obstructive sleep apnea

Presently using CPAP or APAP therapy

1 exclusion criteria prevent from participating

Central or mixed apnea

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Group II

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Northwind Lung Specialists and Sleep Center

Coon Rapids, United StatesOpen Northwind Lung Specialists and Sleep Center in Google Maps

Whitney Sleep Center

Plymouth, United States

Sleep Therapy and Research Center

San Antonio, United States

Completed3 Study Centers