Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)
1 other identifier
interventional
41
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2013
CompletedFirst Posted
Study publicly available on registry
February 26, 2013
CompletedStudy Start
First participant enrolled
February 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2013
CompletedResults Posted
Study results publicly available
January 13, 2025
CompletedJanuary 13, 2025
October 1, 2022
3 months
February 19, 2013
December 6, 2021
January 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
first and second night sleep study
Secondary Outcomes (2)
Unanticipated Adverse Device Effects
first and second night sleep study
Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI)
first and second night sleep study
Study Arms (2)
Transcend followed by REMstar
ACTIVE COMPARATORThe patient will receive treatment with Transcend during the first night sleep study, followed by treatment with the REMstar on the second night.
REMstar followed by Transcend
ACTIVE COMPARATORThe patient will receive treatment with REMstar during the first night sleep study followed by treatment with Transcend on the second night.
Interventions
Eligibility Criteria
You may qualify if:
- Adult 18 years of age or older
- Diagnosis of obstructive sleep apnea
- Presently using CPAP or APAP therapy
You may not qualify if:
- Central or mixed apnea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Northwind Lung Specialists and Sleep Center
Coon Rapids, Minnesota, 55433, United States
Whitney Sleep Center
Plymouth, Minnesota, 55441, United States
Sleep Therapy and Research Center
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melinda Swanson
- Organization
- Bluebird Consulting
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Powell, PhD RPSGT
Sleep Therapy and Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2013
First Posted
February 26, 2013
Study Start
February 27, 2013
Primary Completion
June 10, 2013
Study Completion
June 10, 2013
Last Updated
January 13, 2025
Results First Posted
January 13, 2025
Record last verified: 2022-10