Efficacy of Simple Continuous Positive Airway Pressure on Patients With Obstructive Sleep Apnea

NCT03782844 | Completed

• 1 other identifier: 2011 No. 5
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a common and frequently-occurring disease. The incidence of OSA is more than 4% in general population, and as high as 20% - 40% in the elderly. At present, CPAP machines commonly used for OSA treatment includes traditional pressure fixed single-level CPAP machine and automatic pressure regulation CPAP machine. Studies have shown that the CPAP treatment pressure of OSA patients is normally below 11 cmH2O. Since the condition of OSA patients and the required CPAP treatment pressure may change over time, a CPAP machine with automatic pressure regulation function may theoretically better meet the needs of treatment. However, a recent large-scale clinical study with an average follow-up of four years showed that there was little need to change CPAP treatment pressure after titration. Although different types of CPAP have different functions, the basic principle is to keep the upper airway open and unobstructed to eliminate sleep apnea and hypopnea by continuously applying positive pressure to the upper respiratory tract through an air pump. A complex CPAP machine with functions such as pressure regulation, boost delay, end-expiratory pressure release will cost more than a single-function CPAP machine. Some patients from poor areas, even with severe OSA, may give up treatment when they can not afford CPAP machines that have not yet been included in national health insurance in China. In view of the current economic level in China, it is urgent to find an inexpensive and effective CPAP machine for the treatment of OSA and related complications. Recently, Guangzhou Yinghui Medical Technology Co., Ltd.and State Key Laboratory of Respiratory Disease have developed a new simple CPAP machine. The CPAP treatment pressure is fixed at the factory to 6 cm H2O (SKL), 8 cm H2O (SKM) and 10 cm H2O (SKH). Compared to traditional CPAP machine, only a power switch button is attached on the body, and the additional adjustment devices including display screen are removed, which not only reduces the cost of the CPAP machine, but also facilitates the operation of patients.

Conditions

Sleep Apnea, Obstructive; Continuous Positive Airway Pressure; Polysomnography

Outcome Measures

Primary Outcomes (5)

• Apnea Hypopnea Index

  Total number of apneas and hypopneas×60/total sleep time

  One full night

• Arousal Index

  Total number of arousals×60/total sleep time

  One full night

• Oxygen Desaturation Index

  Total number of oxygen desaturations≥3%×60/total sleep time

  One full night

• Sleep structure

  Sleep stage distribution(N1, N2, N3, NREM)

  One full night

• Adverse effects

  Using questionnaire to assess adverse effects including dyspnea, noise, bloating, et al

  Onefull night

Study Arms (2)

Conventional fixed CPAP and simple CPAP

EXPERIMENTAL

Participants in this group were manually titrated . They were treated with conventional fixed pressure CPAP and Simple CPAP for two separate nights in random order monitored by full polysomnography.

Device: Simple CPAP+Conventional fixed CPAP

Auto CPAP and simple CPAP

EXPERIMENTAL

Participants in this group after being manually titrated were treated with Auto RemStar CPAP and Simple CPAP for two separate nights in random order monitored by full polysomnography.

Device: Simple CPAP + Auto CPAP

Interventions

Simple CPAP+Conventional fixed CPAP DEVICE

Patients used simple CPAP and conventional fixed CPAP during overnight polysomnography.

Conventional fixed CPAP and simple CPAP

Simple CPAP + Auto CPAP DEVICE

Patients used simple CPAP and Auto CPAP during overnight polysomnography.

Auto CPAP and simple CPAP

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate after informed consent
• Males and females, any race and aged≥18yeras
• Objectively confirmed OSA with an apnoea-hypopnoea- index (AHI)≥5/h by overnight polysomnography

You may not qualify if:

• Central Sleep Apnoea/Cheyne Stokes Respiration
• Opioid or sedative use; Alcohol abuse
• Nasal congestion or tonsils more than Ⅱ degrees enlarged
• Optimal treatment CPAP pressure over 10cmH2O
• Poor understanding or being disabled

Sponsors & Collaborators

• State Key Laboratory of Respiratory Disease: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: December 20, 2018
• Study Start: January 2, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 15, 2019
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

CN (1)