NCT04925466

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

June 5, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

June 4, 2021

Last Update Submit

April 7, 2022

Conditions

Obstructive Sleep Apnea of Adult

Keywords

OSACPAPacceptable range

Outcome Measures

Primary Outcomes (4)

  • sleep structure

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

    4 full night

  • arousal index

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

    4 full night

  • Apnea hypopnea index

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

    4 full night

  • Oxygen Desaturation Index

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

    4 full night

Secondary Outcomes (1)

  • Patients preference

    4 full night

Study Arms (2)

Treatment with CPAP at 10cmH2O

EXPERIMENTAL

Patients with OSA will be treated with CPAP at 10cmH2O during sleep.

Device: CPAP at pressure of 10 cmH2O

Treatment with CPAP at minimal effective pressure

EXPERIMENTAL

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

Device: CPAP at minimal effective pressure

Interventions

CPAP at pressure of 10 cmH2ODEVICE

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

Treatment with CPAP at 10cmH2O
CPAP at minimal effective pressureDEVICE

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

Treatment with CPAP at minimal effective pressure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

Location

Related Publications (1)

  • 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.

    PMID: 40130675DERIVED

Study Officials

  • Yuanming Luo, PhD

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 14, 2021

Study Start

June 5, 2021

Primary Completion

July 19, 2021

Study Completion

September 23, 2021

Last Updated

April 8, 2022

Record last verified: 2022-04

Locations

CN(1)