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Comparison of Auto-Adjusting Positive Airway Pressure Devices

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

APAP A (ResMed AirSense AutoSet)

APAP B (Apex iCH Auto)

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

Center of Sleep Medicine, Charité - Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean Apnoea-Hypopnoea-Index (AHI)

AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).

Mean Oxygen Desaturation Index (ODI)

Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour

Secondary Outcome Measures

Obstructive Apnoea Index (OAI)

Number of obstructive apnoeas per hour of nights sleep, Events/hour

Central Apnoea Index (CAI)

Number of central apnoeas during hours of sleep, events/hour

Mixed Apnoea Index (MAI)

Number of obstructive and central apnoeas per hours of nights sleep, Events/hour

Hypopnoea-Index HI

Number of Hypopnoeas per hour of nights sleep, Events/hour

Respiratory Effort Related Arousals RERAs

Number of RERAs per hour of nights sleep, Events/hour

Flow Limitation (%)

Percent of flow-limited breaths in relation to the overall breaths at night.

Mean O2 Saturation

Mean blood oxygen Saturation, %

Full Information

NCT ID

NCT02357706

First Posted

January 27, 2015

Last Updated

April 8, 2020

Sponsor

ResMed

1. Study Identification

Unique Protocol Identification Number

NCT02357706

Brief Title

Comparison of Auto-Adjusting Positive Airway Pressure Devices

Official Title

Comparison of Auto-Adjusting Positive Airway Pressure Devices

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ResMed

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

APAP A (ResMed AirSense AutoSet)

Other Intervention Name(s)

Auto-Adjusting Positive Airway Pressure Device A

Intervention Description

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

Intervention Name(s)

APAP B (Apex iCH Auto)

Other Intervention Name(s)

Auto-Adjusting Positive Airway Pressure Device B

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Apnoea-Hypopnoea-Index (AHI)

Description

AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).

Time Frame

1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)

Title

Mean Oxygen Desaturation Index (ODI)

Description

Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour

Time Frame

1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.

Secondary Outcome Measure Information:

Title

Obstructive Apnoea Index (OAI)

Description

Number of obstructive apnoeas per hour of nights sleep, Events/hour

Time Frame