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Transcend Auto Clinical Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799265
Recruitment Status : Unknown
Verified June 2013 by Somnetics International, Inc..
Recruitment status was:  Active, not recruiting
First Posted : February 26, 2013
Last Update Posted : June 17, 2013
Sponsor:
Information provided by (Responsible Party):
Somnetics International, Inc.

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Somnetics Transcend Auto Device: Respironics REMstar Auto with C-Flex Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcend Auto Clinical Evaluation
Study Start Date : February 2013
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Mean apnea hypopnea index during treatment [ Time Frame: first and second night sleep study ]
    Apnea hypopnea index will be measured during treatment with each of the devices.


Secondary Outcome Measures :
  1. 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.

  2. Mean apnea index and hypopnea index during treatment [ Time Frame: first and second night sleep study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799265


Locations
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United States, Minnesota
Northwind Lung Specialists and Sleep Center
Coon Rapids, Minnesota, United States, 55433
Whitney Sleep Center
Plymouth, Minnesota, United States, 55441
United States, Texas
Sleep Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Somnetics International, Inc.
Investigators
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Principal Investigator: Eric Powell, PhD RPSGT Sleep Therapy and Research Center
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Responsible Party: Somnetics International, Inc.
ClinicalTrials.gov Identifier: NCT01799265    
Other Study ID Numbers: 800383
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: June 17, 2013
Last Verified: June 2013
Keywords provided by Somnetics International, Inc.:
obstructive sleep apnea
OSA
AutoPAP
PAP
sleep disordered breathing
CPAP
Apnea hypopnea index
AHI
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases