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

NCT ID: NCT01799265

Last Updated: 2025-01-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-27

Study Completion Date

2013-06-10

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Somnetics Transcend Auto

Intervention Type DEVICE

Respironics REMstar Auto with C-Flex

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Somnetics Transcend Auto

Intervention Type DEVICE

Respironics REMstar Auto with C-Flex

Intervention Type DEVICE

Interventions

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Somnetics Transcend Auto

Intervention Type DEVICE

Respironics REMstar Auto with C-Flex

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Somnetics International, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Powell, PhD RPSGT

Role: PRINCIPAL_INVESTIGATOR

Sleep Therapy and Research Center

Locations

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Northwind Lung Specialists and Sleep Center

Coon Rapids, Minnesota, United States

Site Status

Whitney Sleep Center

Plymouth, Minnesota, United States

Site Status

Sleep Therapy and Research Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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800383

Identifier Type: -

Identifier Source: org_study_id

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