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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-05

Study Completion Date

2021-09-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea of Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with CPAP at 10cmH2O

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

Group Type EXPERIMENTAL

CPAP at pressure of 10 cmH2O

Intervention Type DEVICE

Patients used CPAP with the pressure of 10 cmH2O during overnight polysomnography

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.

Group Type EXPERIMENTAL

CPAP at minimal effective pressure

Intervention Type DEVICE

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

Interventions

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CPAP at pressure of 10 cmH2O

Patients used CPAP with the pressure of 10 cmH2O during overnight polysomnography

Intervention Type DEVICE

CPAP at minimal effective pressure

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No