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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Device: CPAP at pressure of 10 cmH2O; Device: CPAP at 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510230
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with CPAP at 10cmH2O; Patients with OSA will be treated with CPAP at 10cmH2O during sleep.	Device: CPAP at pressure of 10 cmH2O; Patients used CPAP with the pressure of 10 cmH2O during overnight polysomnography
Experimental: Treatment with CPAP at minimal effective pressure; Patients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.	Device: CPAP at minimal effective pressure; Patients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients preference	Using a questionnaire named preference to record patients preference to 10cmH2O or manual titrated pressure	4 full night

Collaborators and Investigators

• Sponsor: State Key Laboratory of Respiratory Disease
• Investigators: Principal Investigator: Yuanming Luo, PhD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2021
• Primary Completion (Actual): July 19, 2021
• Study Completion (Actual): September 23, 2021

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 5, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: OSA; CPAP; acceptable range
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2021016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No