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Completed

NCT Number: NCT04925466

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

CPAP at pressure of 10 cmH2O

Device

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

CPAP at minimal effective pressure

Device

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

Primary outcomes

  1. sleep structure

    Time frame: 4 full night

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

  2. arousal index

    Time frame: 4 full night

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

  3. Apnea hypopnea index

    Time frame: 4 full night

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

  4. Oxygen Desaturation Index

    Time frame: 4 full night

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

Secondary outcomes

  1. Patients preference

    Time frame: 4 full night

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

Sponsors and collaborators

Lead sponsor

State Key Laboratory of Respiratory Disease

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2021
Registry last updated
Apr 8, 2022

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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