OSAOSANCT01383564
Continuous Positive Airway Pressure Use in Asthma With Moderate to Severe Obstructive Sleep Apnea Patients
A study testing CPAP group and non CPAP group in people with OSA, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- OSA
- What is being tested?
- CPAP group and non CPAP group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nasal Continuous Positive Airway Pressure in Uncontrolled Nocturnal Asthmatic Patients With Moderate Obstructive Sleep Apnea Syndrome
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.
Read the detailed description
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. It may be driven by circadian rhythms of circulating hormones such as epinephrine, cortisol, and melatonin and neural mechanisms such as cholinergic tone. An increase in airway inflammation at night has been reported. This might reflect a reduction in endogenous anti-inflammatory mechanisms. Other factors that have been proposed as possible causes for overnight bronchoconstriction are interruption of bronchodilator or other treatment, allergens in bedding, airway cooling, supine posture, and gastroesophageal reflux (GER).
Prevalence of OSAS in asthma: 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. Large epidemiologic studies demonstrated that asthma patients are more frequently report snoring. In a longitudinal study, asthma was an independent risk factor for development of snoring. OSAS symptoms are highly prevalent in clinic-based populations of well-characterized asthma patients. Polysomnography revealed high frequencies of OSAS (88% and 95.5%) in patients with difficult-to-control asthma.
Common risk factors contributing OSAS asthma: OSAS and asthma share some common risk factors. Fifty percent of the obese in Caucasian populations have OSAS, and among those with OSAS, 40% are obese. However, in a community study of sleep-disordered breathing in middle-aged Chinese men in Hong Kong, the average body mass index (BMI) of habitual snorer was 25.1 kg/m2 and that of OSAS was 27kg/m2, making the contribution of obesity in OSAS less as important as in the western counterpart. Apart from obesity, the prevalence of GER is increased in patients with OSAS. It has been suggested that obesity contributes to the same risk factors for OSAS and GER. However, OSAS patients exhibit significantly more GER than do members of the average population even when one controls for alcohol intake and BMI. GER occurring during sleep is a well-known trigger for nocturnal asthma and can provoke asthma symptoms through vagal reflexes induced by exposure of the esophagus to acid. OSAS-induced acid reflux may play a causative role in triggering asthma symptoms. Another possible etiology for the high prevalence of OSAS symptoms in asthmatic patients is the increased incidence of nasal obstruction in asthmatic patients. The nose is preferred breathing route during sleep, and nasal obstruction contributes to sleep disordered breathing in predisposed individuals. Rhinitis and chronic sinusitis are common conditions that may cause nasal congestion and consequently contribute to upper airway obstruction in OSAS.
The effect of CPAP treatment on asthma control:
CPAP treatment has been shown in prospective clinical studies to have a positive impact on asthma outcome in patients with concomitant OSAS. Although important, these studies included small numbers of participants used nonrandomized designs.
We hypothesize that OSAS contribute to the symptoms related to nocturnal asthma and that CPAP therapy would improve the asthma symptoms, airway hyperactivity and quality of life in patients with nocturnal asthma and OSAS. We aim to assess (1) asthma control, airway responsiveness, daytime sleepiness, cognitive function and health status at baseline and at 3 months after nasal CPAP treatment among our asthma patients with nocturnal symptoms and OSAS; (2) the acceptance and compliance of nasal CPAP treatment.
- Conditions
- OSA
- Being tested
- CPAP group, non CPAP group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP groupProcedure or surgery
Also called CPAP intervention 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
non CPAP groupProcedure or surgery
Also called No CPAP given
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.
| Study group | Role | What they receive |
|---|---|---|
| CPAP group | Active comparator | CPAP group Receives: Procedure: CPAP group |
| non CPAP group | Placebo comparator | non CPAP group Receives: Procedure: non CPAP group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
Spirometry
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.
Measured: 3 months
Epworth Sleepiness Score (ESS)
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.
Measured: 3 months
SF 36 questionnaire
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.
Measured: 3 months
Bronchial challenge test
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanna SS Ng, Chinese University of Hong Kong
- Investigators
- Susanna SS Ng, MBChB, Principal investigator, Chinese Univesrity of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383564
- Sponsor's protocol ID
- Asthma OSA/Ng/2011
- Acronym
- OSA
- Status last verified
- Jul 2016
- First submitted
- 10 Jun 2011
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29992713
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nasal Continuous Positive Airway Pressure in Uncontrolled Nocturnal Asthmatic Patients With Moderate Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT01383564
- Acronym / sponsor ID
- OSA / Asthma OSA/Ng/2011
- Conditions
- OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. It may be driven by circadian rhythms of circulating hormones such as epinephrine, cortisol, and melatonin and neural mechanisms such as cholinergic tone. An increase in airway inflammation at night has been reported. This might reflect a reduction in endogenous anti-inflammatory mechanisms. Other factors that have been proposed as possible causes for overnight bronchoconstriction are interruption of bronchodilator or other treatment, allergens in bedding, airway cooling, supine posture, and gastroesophageal reflux (GER).
Prevalence of OSAS in asthma: 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. Large epidemiologic studies demonstrated that asthma patients are more frequently report snoring. In a longitudinal study, asthma was an independent risk factor for development of snoring. OSAS symptoms are highly prevalent in clinic-based populations of well-characterized asthma patients. Polysomnography revealed high frequencies of OSAS (88% and 95.5%) in patients with difficult-to-control asthma.
Common risk factors contributing OSAS asthma: OSAS and asthma share some common risk factors. Fifty percent of the obese in Caucasian populations have OSAS, and among those with OSAS, 40% are obese. However, in a community study of sleep-disordered breathing in middle-aged Chinese men in Hong Kong, the average body mass index (BMI) of habitual snorer was 25.1 kg/m2 and that of OSAS was 27kg/m2, making the contribution of obesity in OSAS less as important as in the western counterpart. Apart from obesity, the prevalence of GER is increased in patients with OSAS. It has been suggested that obesity contributes to the same risk factors for OSAS and GER. However, OSAS patients exhibit significantly more GER than do members of the average population even when one controls for alcohol intake and BMI. GER occurring during sleep is a well-known trigger for nocturnal asthma and can provoke asthma symptoms through vagal reflexes induced by exposure of the esophagus to acid. OSAS-induced acid reflux may play a causative role in triggering asthma symptoms. Another possible etiology for the high prevalence of OSAS symptoms in asthmatic patients is the increased incidence of nasal obstruction in asthmatic patients. The nose is preferred breathing route during sleep, and nasal obstruction contributes to sleep disordered breathing in predisposed individuals. Rhinitis and chronic sinusitis are common conditions that may cause nasal congestion and consequently contribute to upper airway obstruction in OSAS.
The effect of CPAP treatment on asthma control:
CPAP treatment has been shown in prospective clinical studies to have a positive impact on asthma outcome in patients with concomitant OSAS. Although important, these studies included small numbers of participants used nonrandomized designs.
We hypothesize that OSAS contribute to the symptoms related to nocturnal asthma and that CPAP therapy would improve the asthma symptoms, airway hyperactivity and quality of life in patients with nocturnal asthma and OSAS. We aim to assess (1) asthma control, airway responsiveness, daytime sleepiness, cognitive function and health status at baseline and at 3 months after nasal CPAP treatment among our asthma patients with nocturnal symptoms and OSAS; (2) the acceptance and compliance of nasal CPAP treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP group | Active comparator | Procedure: CPAP groupCPAP group |
| non CPAP group | Placebo comparator | Procedure: non CPAP groupnon CPAP group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP groupAlso: CPAP intervention groupPatients 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 | Procedure or surgery | CPAP group |
| non CPAP groupAlso: No CPAP givenPatients 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. | Procedure or surgery | non CPAP group |
Primary outcome
Asthma control test score
Time frame: 3 months
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.
4 secondary outcomes
Spirometry
Time frame: 3 months
Epworth Sleepiness Score (ESS)
Time frame: 3 months
SF 36 questionnaire
Time frame: 3 months
Bronchial challenge test
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Derived from this study: PubMed 29992713Ng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna SS Ng, MBChB principal investigator
Chinese Univesrity of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP group and non CPAP group in people with OSA, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control test score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01383564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.