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Completed

NCT Number: NCT04128930

Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea

The aim of this trial is to compare two different ways of CPAP titration:

CAP titration with fixed pressure vs. auto-titrating CPAP.

Completed

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

Continuous positive airway pressure (CPAP) for the treatment of moderate obstructive sleep apnea (OSA) is only reimbursed in Belgium after in-laboratory overnight titration. Nevertheless, in a recent clinical practice guideline of the AASM, it is recommended that PAP therapy can be initiated using either in-laboratory titration or auto-titrating CPAP (APAP) at home in OSA patients without significant comorbidities. Indeed, several studies evaluated the impact of titration with APAP at home in these patients and showed that the outcome is comparable with in-hospital titration. Up to now, evidence for home titration with fixed CPAP (and follow-up via telemonitoring) is very limited. The use of sleep laboratory space is costly and limits access for diagnostic studies. This study aims to evaluate whether CPAP titration at home with fixed CPAP produces outcomes equal to those following APAP titration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

PAP titration at home

Device

Fixed CPAP or APAP titration at home

Primary outcomes

  1. CPAP adherence

    Time frame: 3 months

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

Secondary outcomes

  1. Effective pressure level

    Time frame: 2 weeks

    Optimal pressure of CPAP therapy

  2. Residual apnea/hypopnea index

    Time frame: 2 weeks

    Residual respiratory events during treatment with optimal CPAP pressure during PSG

  3. Mask leaks

    Time frame: 2 weeks

    Objective leaks (L/min) during CPAP treatment

  4. Proportion of good titration

    Time frame: 2 weeks

    Number of patients with residual AHI < 10 (objectivated with PSG)

  5. Residual device AHI

    Time frame: 3 months

    Residual AHI as determined from device data

  6. Epworth Sleepiness Scale

    Time frame: 3 months

    Daytime sleepiness (range: 0-24 - higher score means worse outcome)

  7. Blood pressure

    Time frame: 3 months

    Blood pressure measurement

  8. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 3 months

    Sleep quality (range: 0-21 - higher score means worse outcome)

  9. 36-Item Short Form Health Survey

    Time frame: 3 months

    Quality of life (range: 0-100 - higher score means better outcome)

  10. Hospital contacts

    Time frame: 3 months

    Number of contacts with the hospital

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: ATMOS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 16, 2019
Registry last updated
Jul 3, 2024

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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