Comparison of Auto-Adjusting Positive Airway Pressure Devices

NCT ID: NCT02357706

Last Updated: 2020-04-20

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.

Detailed Description

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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

Investigators

Study Groups

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Group 1

Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night.

Group Type ACTIVE_COMPARATOR

APAP A (ResMed AirSense AutoSet)

Intervention Type DEVICE

Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events

APAP B (Apex iCH Auto)

Intervention Type DEVICE

Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events

Group 2

Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night.

Group Type ACTIVE_COMPARATOR

APAP A (ResMed AirSense AutoSet)

Intervention Type DEVICE

Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events

APAP B (Apex iCH Auto)

Intervention Type DEVICE

Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events

Interventions

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APAP A (ResMed AirSense AutoSet)

Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events

Intervention Type DEVICE

APAP B (Apex iCH Auto)

Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events

Intervention Type DEVICE

Other Intervention Names

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Auto-Adjusting Positive Airway Pressure Device A Auto-Adjusting Positive Airway Pressure Device B

Eligibility Criteria

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Inclusion Criteria

* Males aged ≥ 18 years
* Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry
* Naive to CPAP therapy
* Participants willing and able to give written informed consent

Exclusion Criteria

* Participants requiring Bi-level PAP
* Participants requiring supplemental oxygen
* Participants who are pregnant
* Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ingo Fietz, Prof

Role: PRINCIPAL_INVESTIGATOR

Charite Center of Sleep Medicine

Locations

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Center of Sleep Medicine, Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MA240115

Identifier Type: -

Identifier Source: org_study_id

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