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Completed

NCT Number: NCT02357706

Comparison of Auto-Adjusting Positive Airway Pressure Devices

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.

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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

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center of Sleep Medicine, Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

APAP A (ResMed AirSense AutoSet)

Device

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

Other names: Auto-Adjusting Positive Airway Pressure Device A

APAP B (Apex iCH Auto)

Device

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

Other names: Auto-Adjusting Positive Airway Pressure Device B

Primary outcomes

  1. Mean Apnoea-Hypopnoea-Index (AHI)

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

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

  2. Mean Oxygen Desaturation Index (ODI)

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

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

Secondary outcomes

  1. Obstructive Apnoea Index (OAI)

    Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

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

  2. Central Apnoea Index (CAI)

    Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

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

  3. Mixed Apnoea Index (MAI)

    Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

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

  4. Hypopnoea-Index HI

    Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

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

  5. Respiratory Effort Related Arousals RERAs

    Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

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

  6. Flow Limitation (%)

    Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

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

  7. Mean O2 Saturation

    Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

    Mean blood oxygen Saturation, %

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2015
Registry last updated
Apr 20, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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