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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Susanna SS Ng, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01383564
First received: June 10, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
OSA
Procedure: CPAP group
Procedure: non CPAP group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Nasal Continuous Positive Airway Pressure in Uncontrolled Nocturnal Asthmatic Patients With Moderate Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Asthma control test score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Spirometry [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The most important aspects of spirometry are the forced vital capacity (FVC), which is the volume delivered during an expiration made as forcefully and completely as possible starting from full inspiration, and the forced expiratory volume in one second(FEV1), which is the volume delivered in the first second of an FVC manoeuvre. The value of FEV1 and FVC will be monitored in baseline and 3 months.

  • Epworth Sleepiness Score (ESS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The Epworth Sleepiness Scale (ESS) is a questionnaire for assessing daytime sleepiness. It was first described in 1991 as a simple, self-administered questionnaire. The questionnaire is based on eight common situations in life. Subjects are asked to rate on a scale of 0-3 about how likely they would fall asleep or doze off in these circumstances. This gives a total score of 0 to 24 in each subject.

  • SF 36 questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The Short Form Health Survey (SF-36) is a survey of patient health. It is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.

  • Bronchial challenge test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    A bronchial challenge test is one method of assessing airway responsiveness in which patient breathes in nebulised methacholine and then will be assessed by measuring the Forced Expiratory Volume in one second (FEV1).


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CPAP group Procedure: CPAP group
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
Other Name: CPAP intervention group
Placebo Comparator: non CPAP group Procedure: non CPAP group
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.
Other Name: No CPAP given

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383564

Contacts
Contact: Susanna SS Ng, MBChB 852 2632 2211 drsssng123@yahoo.com.hk

Locations
China, Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong, China
Contact: S S Ng, MBChB    852 2632 2211    drsssng123@yahoo.com.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Susanna SS Ng, MBChB Chinese Univesrity of Hong Kong
  More Information

No publications provided

Responsible Party: Susanna SS Ng, Honorary Clinical Tutor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01383564     History of Changes
Other Study ID Numbers: Asthma OSA/Ng/2011
Study First Received: June 10, 2011
Last Updated: March 6, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014