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OpenTrials
Completed

NCT Number: NCT01799265

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwind Lung Specialists and Sleep Center, Coon Rapids, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somnetics Transcend Auto

Device

Respironics REMstar Auto with C-Flex

Device

Primary outcomes

  1. Mean Apnea Hypopnea Index (AHI) During Treatment

    Time frame: first and second night sleep study

    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.

Secondary outcomes

  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 Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI)

    Time frame: first and second night sleep study

    Mean hypopnea index will be measure during treatment. HI will be measured during treatment with each of the devices. HI = 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. HI was measured by the devices and independently by a central laboratory. Results are reported as the Mean Differences between PSG and Device Hypopnea Index. These differences can be reported as negative values.

Sponsors and collaborators

Lead sponsor

Somnetics International, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2013
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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