Transcend Auto Clinical Evaluation

Obstructive Sleep Apnea Clinical Trial

Official title:

Transcend Auto Clinical Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799265
• Other study ID #: 800383
• Status: Completed
• Phase: N/A
• Start date: February 27, 2013
• Est. completion date: June 10, 2013

Study information

• Verified date: December 2021
• Source: Somnetics International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 10, 2013
• Est. primary completion date: June 10, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Somnetics Transcend Auto

• Respironics REMstar Auto with C-Flex

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Somnetics International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean apnea hypopnea index during treatment	Apnea hypopnea index will be measured during treatment with each of the devices.	first and second night sleep study
Secondary	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.	first and second night sleep study
Secondary	Mean apnea index and hypopnea index during treatment	Mean apnea index and hypopnea index will be measure during treatment	first and second night sleep study