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

April 7, 2022 updated by: Yuan-Ming Luo, State Key Laboratory of Respiratory Disease

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
4 full night
arousal index
Time Frame: 4 full night
total number of arousal events/total sleep time(h)
4 full night
Apnea hypopnea index
Time Frame: 4 full night
Total number of apneas and hypopneas/total sleep time (h)
4 full night
Oxygen Desaturation Index
Time Frame: 4 full night
Total number of oxygen desaturations≥3% /total sleep time(h)
4 full night

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients preference
Time Frame: 4 full night
Using a questionnaire named preference to record patients preference to 10cmH2O or manual titrated pressure
4 full night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State Key Laboratory of Respiratory Disease

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuanming Luo, PhD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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