Continuous Positive Airway Pressure Use in Asthma With Moderate to Severe Obstructive Sleep Apnea Patients

NCT01383564 | Completed

• 1 other identifier: Asthma OSA/Ng/2011
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea syndrome (OSAS) and asthma are both common disorders in Hong Kong, with prevalence of at least 4% among the middle-aged male Hong Kong (HK) Chinese populations and 7.2% in young adults respectively. OSAS is characterized by repetitive episodes of upper airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor health status. Continuous positive airway pressure (CPAP) is the first line of therapy for sleep apnea. CPAP provides a pneumatic stent for the upper airway, eliminating the airway collapse during inspiration. Asthma is a chronic inflammatory disorder of airways, characterized by airway hyperresponsiveness that leads to recurrent episodes of wheezing, breathless, chest tightness, and coughing, particularly at night or in the early morning. Nocturnal asthma is not a different condition from asthma and is defined as a variable worsening of asthma at night, in which the mechanisms are not completely understood. The prevalence of OSAS in asthmatic patients has not yet been studied, but several studies have reported an increased prevalence of OSAS symptoms in asthmatic patients. OSAS and asthma share some common risk factors, which include obesity, gastroesophageal reflux and rhinitis. CPAP treatment has been shown in prospective clinical studies to have a positive impact on asthma outcome in patients with concomitant OSAS, for example, improvement of asthma related quality of life in subjects with stable mild-to-moderate asthma, but there was no change in the airway responsiveness or forced expiratory volume in one second. Although important, these studies included small numbers of participants used nonrandomized designs. This study is to assess the impact of CPAP treatment on asthma control among patients with nocturnal symptoms and moderate OSAS.

Conditions

OSA

Outcome Measures

Primary Outcomes (1)

• Asthma control test score

  All patients with moderate OSAS will be assessed by an easy assessment tool for asthma control, known as the Asthma Control Test (ACT). It is a validated questionnaire in which various studies have proved its correlation with the clinical asthma control. The ACT consisted of five items; for each item, five options are provided pertaining to asthma control during the past 4 weeks. Each item is scored according to a 5-point scale, and the item scores are totalled for assessing asthma control, with higher total scores indicating better asthma control.

  3 months

Secondary Outcomes (4)

• Spirometry

  3 months

• Epworth Sleepiness Score (ESS)

  3 months

• SF 36 questionnaire

  3 months

• Bronchial challenge test

  3 months

Study Arms (2)

CPAP group

ACTIVE COMPARATOR

CPAP group

Procedure: CPAP group

non CPAP group

PLACEBO COMPARATOR

non CPAP group

Procedure: non CPAP group

Interventions

CPAP group PROCEDURE

Patients will be given a CPAP education program by our respiratory nurse supplemented by education brochure and a video. Attended overnight CPAP titration will be performed with the auto-titrating device. The CPAP level for each patient in the therapeutic CPAP arm is set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night as determined by the overnight CPAP titration study. Patients in the CPAP therapy will be provided careful mask-fitting, chin strap to prevent mouth leak, regular review by our nurses, a basic CPAP device with intrinsic time clock to monitor CPAP usage and standard stroke rehabilitation programme. Patients on conservative treatment will only be offered standard treatment for asthma

Also known as: CPAP intervention group

CPAP group

non CPAP group PROCEDURE

Patients who are randomised to non CPAP group will receive general health advice and no CPAP therapy will be arranged for them during the study period.

Also known as: No CPAP given

non CPAP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• at least one nocturnal awakening or early morning awakening caused by asthmatic symptoms (cough, wheeze, chest tightness, and breathlessness)
• habitual snoring; able to give consent for joining the study

You may not qualify if:

• active smoking or quit smoking \<6 months or smoking history \>10 pack-years
• Cardiac failure
• cerebrovascular disease
• lung disease except asthma
• dementia or poor hand function that would inhibit the patients cooperating the sleep study or CPAP treatment

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

Related Publications (1)

• Ng SSS, Chan TO, To KW, Chan KKP, Ngai J, Yip WH, Lo RLP, Ko FWS, Hui DSC. Continuous positive airway pressure for obstructive sleep apnoea does not improve asthma control. Respirology. 2018 Nov;23(11):1055-1062. doi: 10.1111/resp.13363. Epub 2018 Jul 10.

  PMID: 29992713 DERIVED

Study Officials

• Susanna SS Ng, MBChB

  Chinese Univesrity of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Tutor

Study Record Dates

• First Submitted: June 10, 2011
• First Posted: June 28, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 29, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)