Obstructive Sleep ApneaNCT02357706

Comparison of Auto-Adjusting Positive Airway Pressure Devices

A study testing APAP A (ResMed AirSense AutoSet) and APAP B (Apex iCH Auto) in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: APAP A (ResMed AirSense AutoSet) and APAP B (Apex iCH Auto)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteGermany
Study dates: Jan 2015to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

Center of Sleep Medicine, Charité - Universitätsmedizin Berlin
Berlin, 10117

Other trials in Germany

About this study

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.

Conditions: Obstructive Sleep Apnea
Being tested: APAP A (ResMed AirSense AutoSet), APAP B (Apex iCH Auto)
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

APAP A (ResMed AirSense AutoSet)Device
Also called Auto-Adjusting Positive Airway Pressure Device A
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)Device
Also called Auto-Adjusting Positive Airway Pressure Device B
Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events

Study groups in NCT02357706
Study group	Role	What they receive
Group 1	Active comparator	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. Receives: Device: APAP A (ResMed AirSense AutoSet); Device: APAP B (Apex iCH Auto)
Group 2	Active comparator	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. Receives: Device: APAP A (ResMed AirSense AutoSet); Device: APAP B (Apex iCH Auto)

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Apnoea-Hypopnoea-Index (AHI)
AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).
Measured: 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)
Mean Oxygen Desaturation Index (ODI)
Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour
Measured: 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.

Secondary outcomes (7)

Obstructive Apnoea Index (OAI)
Number of obstructive apnoeas per hour of nights sleep, Events/hour
Measured: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Central Apnoea Index (CAI)
Number of central apnoeas during hours of sleep, events/hour
Measured: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Mixed Apnoea Index (MAI)
Number of obstructive and central apnoeas per hours of nights sleep, Events/hour
Measured: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Hypopnoea-Index HI
Number of Hypopnoeas per hour of nights sleep, Events/hour
Measured: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Respiratory Effort Related Arousals RERAs
Number of RERAs per hour of nights sleep, Events/hour
Measured: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Flow Limitation (%)
Percent of flow-limited breaths in relation to the overall breaths at night.
Measured: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Mean O2 Saturation
Mean blood oxygen Saturation, %
Measured: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Dec 2015

First posted6 Feb 2015 (estimated)
Study startJan 2015
Primary completionJun 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by ResMedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02357706
Sponsor's protocol ID: MA240115
Status last verified: Apr 2020
First submitted: 27 Jan 2015
Last updated: 20 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Auto-Adjusting Positive Airway Pressure Devices
ClinicalTrials.gov ID: NCT02357706
Acronym / sponsor ID: MA240115
Conditions: Obstructive Sleep Apnea
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: ResMedIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Jun 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 6 Feb 2015 (estimated)
Results: Posted 20 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Group 1	Active comparator	Device: APAP A (ResMed AirSense AutoSet), Device: APAP B (Apex iCH Auto)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 2	Active comparator	Device: APAP A (ResMed AirSense AutoSet), Device: APAP B (Apex iCH Auto)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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
APAP A (ResMed AirSense AutoSet)Also: Auto-Adjusting Positive Airway Pressure Device ACommercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events	Device	Group 1, Group 2
APAP B (Apex iCH Auto)Also: Auto-Adjusting Positive Airway Pressure Device BCommercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events	Device	Group 1, Group 2

Primary outcome

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).
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

7 secondary outcomes

Obstructive Apnoea Index (OAI)
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Central Apnoea Index (CAI)
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Mixed Apnoea Index (MAI)
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Hypopnoea-Index HI
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Respiratory Effort Related Arousals RERAs
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Flow Limitation (%)
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B
Mean O2 Saturation
Time frame: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

Results and safety

Results posted to the registry on 20 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
APAP A, Then APAP B	10	10
APAP B, Then APAP A	10	10

Primary outcome: Mean Apnoea-Hypopnoea-Index (AHI)

Time frame: 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex). Mean (Standard Deviation). Unit: events/hour

Measure	APAP A (AirSense Auto Set) n = 20	APAP B (Apex iCH Auto) n = 20
Value	6.21 (6.73)	7.45 (7.57)

APAP A (AirSense Auto Set) vs APAP B (Apex iCH Auto): Mean Difference (Final Values): 1.24, p = 0.537, t-test, 1 sided
APAP A (AirSense Auto Set) vs APAP B (Apex iCH Auto): Mean Difference (Net): 1.24, p = 0.05, t-test, 1 sided

Population analysed: 20 patients have used APAP A, for which the primary outcome was calculated. The same 20 patients have used APAP B for which the Primary outcome was calculated.

Primary outcome: Mean Oxygen Desaturation Index (ODI)

Time frame: 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.. Mean (Standard Deviation). Unit: events/hour

Measure	APAP A (AirSense) n = 20	APAP B (Apex) n = 20
Value	7.94 (8.10)	10.63 (9.5)

APAP A (AirSense) vs APAP B (Apex): Mean Difference (Net): 2.69, p = 0.205, t-test, 1 sided
APAP A (AirSense) vs APAP B (Apex): Mean Difference (Net): 2.69, p = 0.134, t-test, 1 sided

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
APAP A (AirSense)	0 of 20 (0%)	0 of 20 (0%)	0 of 20
APAP B (Apex)	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ingo Fietz, Prof principal investigator

Charite Center of Sleep Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing APAP A (ResMed AirSense AutoSet) and APAP B (Apex iCH Auto) in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Apnoea-Hypopnoea-Index (AHI) (time frame: 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02357706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.