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

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04925466
• Other study ID #: 2021016
• Status: Completed
• Phase: N/A
• Start date: June 5, 2021
• Est. completion date: September 23, 2021

Study information

• Verified date: April 2022
• Source: State Key Laboratory of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 23, 2021
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP at pressure of 10 cmH2O
Patients used CPAP with the pressure of 10 cmH2O during overnight polysomnography
• CPAP at minimal effective pressure
Patients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
State Key Laboratory of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep structure	Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed)	4 full night
Primary	arousal index	total number of arousal events/total sleep time(h)	4 full night
Primary	Apnea hypopnea index	Total number of apneas and hypopneas/total sleep time (h)	4 full night
Primary	Oxygen Desaturation Index	Total number of oxygen desaturations=3% /total sleep time(h)	4 full night
Secondary	Patients preference	Using a questionnaire named preference to record patients preference to 10cmH2O or manual titrated pressure	4 full night