NCT04128930

Brief Summary

The aim of this trial is to compare two different ways of CPAP titration: CAP titration with fixed pressure vs. auto-titrating CPAP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

October 14, 2019

Last Update Submit

July 2, 2024

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

  • CPAP adherence

    Usage of the device (mean number of hours/day)

    3 months

Secondary Outcomes (10)

  • Effective pressure level

    2 weeks

  • Residual apnea/hypopnea index

    2 weeks

  • Mask leaks

    2 weeks

  • Proportion of good titration

    2 weeks

  • Residual device AHI

    3 months

  • +5 more secondary outcomes

Study Arms (2)

Fixed CPAP titration at home

EXPERIMENTAL

Patients will start CPAP treatment with a pressure that is calculated by the following formula (predicted pressure = (0.13 x BMI) + (0.16x neck circumference in cm) + (0.04 x AHI)) with a maximal pressure of 10 cmH2O. After 3 nights and after 7 nights, CPAP data will be remotely evaluated and pressure will be adapted based on the following rules: * After 3 nights: median obstructive AHI\<5/h: decrease pressure with 2 cmH2O; median obstructive AHI\>5/h: increase with 2cmH2O * After 7 nights: median obstructive AHI\>5/h of 4 nights after last adaptation: increase with 2 cmH2O

Device: PAP titration at home

APAP titration at home

ACTIVE COMPARATOR

Patients will start CPAP treatment with an auto-adjusting CPAP device with pressure levels between 4 and 12 cmH2O. After 7 nights of titration, the optimal pressure will be determined by analyzing the median of the nightly pressure that included 95% of the periods (percentile 95). CPAP treatment will be continued with this fixed optimal pressure.

Device: PAP titration at home

Interventions

PAP titration at homeDEVICE

Fixed CPAP or APAP titration at home

APAP titration at homeFixed CPAP titration at home

Eligibility Criteria

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

You may qualify if:

  • moderate OSA (obstructive AHI 15-30/u on initial PSG)

You may not qualify if:

  • Presence of hypoventilation
  • Presence of central sleep apnea (central AHI ≥ 15)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dries Testelmans, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 16, 2019

Study Start

October 14, 2019

Primary Completion

October 1, 2021

Study Completion

December 31, 2021

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)