NCT02357706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

April 20, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

January 27, 2015

Results QC Date

April 12, 2017

Last Update Submit

April 8, 2020

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Mean Apnoea-Hypopnoea-Index (AHI)

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

    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

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

Secondary Outcomes (7)

  • Obstructive Apnoea Index (OAI)

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

  • Central Apnoea Index (CAI)

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

  • Mixed Apnoea Index (MAI)

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

  • Hypopnoea-Index HI

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

  • Respiratory Effort Related Arousals RERAs

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

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Device: APAP A (ResMed AirSense AutoSet)Device: APAP B (Apex iCH Auto)

Interventions

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

Also known as: Auto-Adjusting Positive Airway Pressure Device A
Group 1Group 2
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

Also known as: Auto-Adjusting Positive Airway Pressure Device B
Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Sleep Medicine, Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Prof Dr med Ingo Fietze
Organization
Charite Department of Sleepmedizin
ingo.fietze@charite.de
+49 30 450 513 122

Study Officials

  • Ingo Fietz, Prof

    Charite Center of Sleep Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2015

First Posted

February 6, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

April 20, 2020

Results First Posted

April 20, 2020

Record last verified: 2020-04

Locations

DE(1)