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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea of Adult
• Interventions: Device: CPAP at pressure of 10 cmH2O; Device: CPAP at minimal effective pressure

• Registration Number: NCT04925466
• Lead Sponsor: State Key Laboratory of Respiratory Disease

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.

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.

Study Timeline

• Study First Submitted: 2021-06-04
• Study Start: 2021-06-05
• Study First Submitted QC: 2021-06-05
• Study First Posted: 2021-06-14
• Primary Completion: 2021-07-19
• Study Completion: 2021-09-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. reported snore, apnea and daytime sleepiness;
2. 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;
3. willing to participate after informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment with CPAP at 10cmH2O	CPAP at pressure of 10 cmH2O	Patients with OSA will be treated with CPAP at 10cmH2O during sleep.
Treatment with CPAP at minimal effective pressure	CPAP at minimal effective pressure	Patients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.

Primary Outcome Measures

Name	Time	Method
sleep structure	4 full night	Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed)
arousal index	4 full night	total number of arousal events/total sleep time(h)
Apnea hypopnea index	4 full night	Total number of apneas and hypopneas/total sleep time (h)
Oxygen Desaturation Index	4 full night	Total number of oxygen desaturations≥3% /total sleep time(h)

Secondary Outcome Measures

Name	Time	Method
Patients preference	4 full night	Using a questionnaire named preference to record patients preference to 10cmH2O or manual titrated pressure

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China