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Obstructive Sleep Apnea of AdultNCT04925466

Acceptable Pressure Range for Continuous Positive Airway Pressure(CPAP) Treatment

A study testing CPAP at pressure of 10 cmH2O and CPAP at minimal effective pressure in people with Obstructive Sleep Apnea of Adult, run by State Key Laboratory of Respiratory Disease at 1 site in China.

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

Compliance of continuous positive airway pressure （CPAP） derived from auto-titration is similar to that derived from manual titration, although pressure derived from the former was usually 2-5 cmH2O higher than the latter. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obstructive Sleep Apnea of Adult
What is being tested?
CPAP at pressure of 10 cmH2O and CPAP at minimal effective pressure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
5 Jun 2021to 23 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • reported snore, apnea and daytime sleepiness;
  • a diagnosis of obstructive sleep apnea with polysomnography according to ASSM guideline(apnoea-hypopnea-index(AHI)≥5 events/h) and need to be treated with continuous positive airway pressure;
  • willing to participate after informed consent.

Who cannot join

  • Evidence of severe coronary or cerebral, cardiovascular disease and significant memory, perceptual or behavioural disorder;
  • Severe respiratory disease defined as severe chronic obstructive pulmonary disease(ie. FEV1/FVC<70% and FEV1<50%predicted) or resting awake SaO2<90%
  • Have known contraindications with CPAP, like current pneumothorax and hemoptysis, et al.
  • Central sleep apnea>10 events/h；
  • Frequent nasal congestion；
  • Optimal treatment CPAP pressure(by manual titration) equal or higher than 10cmH2O.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510230

Other trials in China

About this study

Official title: Comparison of 10cmH2O and Manual Titrated Pressure in Treatment of Obstructive Sleep Apnea(OSA) Patients

Compliance of continuous positive airway pressure （CPAP） derived from auto-titration is similar to that derived from manual titration, although pressure derived from the former was usually 2-5 cmH2O higher than the latter. Therefore the Investigators hypothesize that accurate titration maybe not necessary for successful treatment of obstructive sleep apnea (OSA) as long as CPAP pressure was not lower than the minimal effective pressure.

Read the detailed description

Study Design: A randomized, cross-over and double-blind study. Objective: To compare the pressure of 10 cmH2O and minimal effective pressure derived from manual titration on the effect of CPAP treatment in OSA. Methods: Patients with suspected OSA (age, body mass index and symptom) to be referred to a sleep centre were recruited. Patients with OSA confirmed by overnight full polysomnography (PSG) were invited to do standard overnight manual titration under PSG based on the Academy of Sleep Medicine (AASM) manual guidelines. Patients whose manual titration pressure lower than 10cmH2O and willing to participate in the study were invited to repeat two more nights (3th PSG and 4th PSG) under CPAP pressure at both 10cmH2O and the pressure derived from manual titration in random order. The sleep apnea-hypopnea index (AHI), obstructive sleep apnea index (OHI), arousal index (ArI), oxygen desaturation index (ODI), sleep structure, and treatment preference were to be observed.

Being tested
CPAP at pressure of 10 cmH2O, CPAP at minimal effective pressure
Keywords
OSA, CPAP, acceptable range

What participants receive

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

  • CPAP at pressure of 10 cmH2ODevice

    Patients used CPAP with the pressure of 10 cmH2O during overnight polysomnography

  • CPAP at minimal effective pressureDevice

    Patients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.

Study groups in NCT04925466
Study groupRoleWhat they receive
Treatment with CPAP at 10cmH2OExperimentalPatients with OSA will be treated with CPAP at 10cmH2O during sleep.
Receives: Device: CPAP at pressure of 10 cmH2O
Treatment with CPAP at minimal effective pressureExperimentalPatients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.
Receives: Device: CPAP at minimal effective pressure

What is being measured

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

  1. sleep structure

    Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed)

    Measured: 4 full night

  2. arousal index

    total number of arousal events/total sleep time(h)

    Measured: 4 full night

  3. Apnea hypopnea index

    Total number of apneas and hypopneas/total sleep time (h)

    Measured: 4 full night

  4. Oxygen Desaturation Index

    Total number of oxygen desaturations≥3% /total sleep time(h)

    Measured: 4 full night

Secondary outcomes (1)

  1. Patients preference

    Using a questionnaire named preference to record patients preference to 10cmH2O or manual titrated pressure

    Measured: 4 full night

Timeline

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

  1. First posted14 Jun 2021
  2. Study start5 Jun 2021
  3. Primary completion19 Jul 2021
  4. Study completion23 Sep 2021

Resources

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
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925466
Sponsor's protocol ID
2021016
Status last verified
Apr 2022
First submitted
4 Jun 2021
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wang L, Chen Y, Wei Q, Wu Y, Huang C, Liang S, Steier J, Catcheside P, Eckert D, Wellman A, Luo Y. Fixed CPAP at 10 cmH 2O May Replace Manual Titration in Moderate to Severe OSA Patients: A Preliminary Randomised Controlled Trial. Respirology. 2025 Aug;30(8):770-778. doi: 10.1111/resp.70037. Epub 2025 Mar 25.

    PubMed 40130675

Questions about this trial

What is this clinical trial studying?

A study testing CPAP at pressure of 10 cmH2O and CPAP at minimal effective pressure in people with Obstructive Sleep Apnea of Adult, run by State Key Laboratory of Respiratory Disease at 1 site in China.

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 3 inclusion and 6 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 8 Apr 2022. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

sleep structure (time frame: 4 full night). The study lists 4 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 NCT04925466, which also lists 1 linked publication.

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 8 Apr 2022.

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