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

Primary Purpose

Obstructive Sleep Apnea of Adult

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CPAP at pressure of 10 cmH2O
CPAP at minimal effective pressure
Sponsored by
State Key Laboratory of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea of Adult focused on measuring OSA, CPAP, acceptable range

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment with CPAP at 10cmH2O

Treatment with CPAP at minimal effective pressure

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 4, 2021
Last Updated
April 7, 2022
Sponsor
State Key Laboratory of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT04925466
Brief Title
Acceptable Pressure Range for Continuous Positive Airway Pressure(CPAP) Treatment
Official Title
Comparison of 10cmH2O and Manual Titrated Pressure in Treatment of Obstructive Sleep Apnea(OSA) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2021 (Actual)
Primary Completion Date
July 19, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Key Laboratory of Respiratory Disease

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult
Keywords
OSA, CPAP, acceptable range

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with CPAP at 10cmH2O
Arm Type
Experimental
Arm Description
Patients with OSA will be treated with CPAP at 10cmH2O during sleep.
Arm Title
Treatment with CPAP at minimal effective pressure
Arm Type
Experimental
Arm Description
Patients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.
Intervention Type
Device
Intervention Name(s)
CPAP at pressure of 10 cmH2O
Intervention Description
Patients used CPAP with the pressure of 10 cmH2O during overnight polysomnography
Intervention Type
Device
Intervention Name(s)
CPAP at minimal effective pressure
Intervention Description
Patients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.
Primary Outcome Measure Information:
Title
sleep structure
Description
Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed)
Time Frame
4 full night
Title
arousal index
Description
total number of arousal events/total sleep time(h)
Time Frame
4 full night
Title
Apnea hypopnea index
Description
Total number of apneas and hypopneas/total sleep time (h)
Time Frame
4 full night
Title
Oxygen Desaturation Index
Description
Total number of oxygen desaturations≥3% /total sleep time(h)
Time Frame
4 full night
Secondary Outcome Measure Information:
Title
Patients preference
Description
Using a questionnaire named preference to record patients preference to 10cmH2O or manual titrated pressure
Time Frame
4 full night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanming Luo, PhD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510230
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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