Back to resultsTranscend Auto Clinical Evaluation
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Somnetics Transcend Auto
Respironics REMstar Auto with C-Flex
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, OSA, AutoPAP, PAP, sleep disordered breathing, CPAP, Apnea hypopnea index, AHI
Eligibility Criteria
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
Sites / Locations
- Northwind Lung Specialists and Sleep Center
- Whitney Sleep Center
- Sleep Therapy and Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transcend followed by REMstar
REMstar followed by Transcend
Arm Description
The patient will receive treatment with Transcend during the first night sleep study, followed by treatment with the REMstar on the second night.
The patient will receive treatment with REMstar during the first night sleep study followed by treatment with Transcend on the second night.
Outcomes
Primary Outcome Measures
Mean apnea hypopnea index during treatment
Apnea hypopnea index will be measured during treatment with each of the devices.
Secondary Outcome Measures
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.
Mean apnea index and hypopnea index during treatment
Mean apnea index and hypopnea index will be measure during treatment
Full Information
NCT ID
NCT01799265
First Posted
February 19, 2013
Last Updated
December 1, 2021
Sponsor
Somnetics International, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01799265
Brief Title
Transcend Auto Clinical Evaluation
Official Title
Transcend Auto Clinical Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2013 (undefined)
Primary Completion Date
June 10, 2013 (Actual)
Study Completion Date
June 10, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Somnetics International, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, OSA, AutoPAP, PAP, sleep disordered breathing, CPAP, Apnea hypopnea index, AHI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcend followed by REMstar
Arm Type
Active Comparator
Arm Description
The patient will receive treatment with Transcend during the first night sleep study, followed by treatment with the REMstar on the second night.
Arm Title
REMstar followed by Transcend
Arm Type
Active Comparator
Arm Description
The patient will receive treatment with REMstar during the first night sleep study followed by treatment with Transcend on the second night.
Intervention Type
Device
Intervention Name(s)
Somnetics Transcend Auto
Intervention Type
Device
Intervention Name(s)
Respironics REMstar Auto with C-Flex
Primary Outcome Measure Information:
Title
Mean apnea hypopnea index during treatment
Description
Apnea hypopnea index will be measured during treatment with each of the devices.
Time Frame
first and second night sleep study
Secondary Outcome Measure Information:
Title
unanticipated adverse device effects
Description
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
Title
Mean apnea index and hypopnea index during treatment
Description
Mean apnea index and hypopnea index will be measure during treatment
Time Frame
first and second night sleep study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Powell, PhD RPSGT
Organizational Affiliation
Sleep Therapy and Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwind Lung Specialists and Sleep Center
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Whitney Sleep Center
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Sleep Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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Transcend Auto Clinical Evaluation
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