OSANCT01828216
Ambulatory Versus Conventional Approach Diagnosing OSA
A study testing Home sleep study and conventional polysomnography in people with OSA, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Very few studies have examined different models of care involving initial ambulatory home-based diagnosis in diagnosing obstructive sleep apnea (OSA), identifying patients who benefit from continuous positive airway pressure (CPAP), and reducing the need for polysomnography (PSG). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- OSA
- What is being tested?
- Home sleep study and conventional polysomnography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- symptoms of OSA with home sleep study AHI >= 15/hr.
Who cannot join
- unstable cardiovascular diseases (e.g. recent unstable angina, myocardial infarction, stroke or transient ischemic attack within the previous 6 months or severe left ventricular failure)
- neuromuscular disease affecting or potentially affecting respiratory muscles
- moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake oxygen saturation of <92%
- psychiatric disease that limits the ability to give informed consent or complete the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study Assessing the Role of an Ambulatory Approach Versus the Conventional Approach in Managing Suspected Obstructive Sleep Apnoea Syndrome
Very few studies have examined different models of care involving initial ambulatory home-based diagnosis in diagnosing obstructive sleep apnea (OSA), identifying patients who benefit from continuous positive airway pressure (CPAP), and reducing the need for polysomnography (PSG). This study aims to assess the role of an ambulatory approach with home diagnostic sleep study. We hypothesize that the ambulatory approach is as good as the conventional approach in managing OSA in terms of improvement of clinical outcome but the former approach will lead to substantial cost savings.
Read the detailed description
We conducted a prospective, randomized, controlled continuous positive airway pressure (CPAP) parallel study on new referrals to the Respiratory Clinic, Prince of Wales Hospital, with suspected obstructive sleep apnea (OSAS). OSAS was defined by apnea-hypopnea index(AHI) 5/hr or more of sleep plus excessive daytime sleepiness or two of the following symptoms: choking or gasping during sleep, recurrent awakenings from sleep, unrefreshed sleep, daytime fatigue, and impaired concentration. All patients with suspected OSAS underwent assessment at the clinic with the Epworth sleepiness score(ESS) and symptoms evaluation. Patients who had ESS score>9 or at least two OSAS symptoms as described above were invited to join the study. They were randomized into either group A)home-based management approach or group B)hospital-based management approach by a random table by a third party not involved in the trial.
- Conditions
- OSA
- Being tested
- Home sleep study, conventional polysomnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home sleep studyDevice
The home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events
conventional polysomnographyDevice
conventional type I sleep study according to international guidelines
| Study group | Role | What they receive |
|---|---|---|
| Conventional polysomnography | Active comparator | Conventional PSG will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest \& abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer \& supplemented by oronasal airflow thermistor, \& finger pulse oximetry. Receives: Device: conventional polysomnography |
| Home sleep study | Active comparator | The home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events. Receives: Device: Home sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought.
Measured: Baseline and 3 months
Secondary outcomes (1)
Difference in Healthcare Costs Between Ambulatory and Hospital Approach
Measured: within 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof David Shu Cheong Hui, Chinese University of Hong Kong
- Investigators
- David Hui, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828216
- Sponsor's protocol ID
- amb_hosp_OSA
- Status last verified
- Feb 2016
- First submitted
- 8 Apr 2013
- Last updated
- 29 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Ng SS, Tam W, Chan TO, To KW, Ngai J, Chan KKP, Yip WH, Lo RL, Yiu K, Ko FW, Hui DS. Use of Berlin questionnaire in comparison to polysomnography and home sleep study in patients with obstructive sleep apnea. Respir Res. 2019 Feb 22;20(1):40. doi: 10.1186/s12931-019-1009-y.
PubMed 30795760
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Assessing the Role of an Ambulatory Approach Versus the Conventional Approach in Managing Suspected Obstructive Sleep Apnoea Syndrome
- ClinicalTrials.gov ID
- NCT01828216
- Acronym / sponsor ID
- amb_hosp_OSA
- Conditions
- OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Posted 29 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Very few studies have examined different models of care involving initial ambulatory home-based diagnosis in diagnosing obstructive sleep apnea (OSA), identifying patients who benefit from continuous positive airway pressure (CPAP), and reducing the need for polysomnography (PSG). This study aims to assess the role of an ambulatory approach with home diagnostic sleep study. We hypothesize that the ambulatory approach is as good as the conventional approach in managing OSA in terms of improvement of clinical outcome but the former approach will lead to substantial cost savings.
Detailed description
We conducted a prospective, randomized, controlled continuous positive airway pressure (CPAP) parallel study on new referrals to the Respiratory Clinic, Prince of Wales Hospital, with suspected obstructive sleep apnea (OSAS). OSAS was defined by apnea-hypopnea index(AHI) 5/hr or more of sleep plus excessive daytime sleepiness or two of the following symptoms: choking or gasping during sleep, recurrent awakenings from sleep, unrefreshed sleep, daytime fatigue, and impaired concentration. All patients with suspected OSAS underwent assessment at the clinic with the Epworth sleepiness score(ESS) and symptoms evaluation. Patients who had ESS score>9 or at least two OSAS symptoms as described above were invited to join the study. They were randomized into either group A)home-based management approach or group B)hospital-based management approach by a random table by a third party not involved in the trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional polysomnography | Active comparator | Device: conventional polysomnographyConventional PSG will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest \& abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer \& supplemented by oronasal airflow thermistor, \& finger pulse oximetry. |
| Home sleep study | Active comparator | Device: Home sleep studyThe home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptoms of OSA with home sleep study AHI >= 15/hr.
Key exclusion criteria (4 listed)
- unstable cardiovascular diseases (e.g. recent unstable angina, myocardial infarction, stroke or transient ischemic attack within the previous 6 months or severe left ventricular failure)
- neuromuscular disease affecting or potentially affecting respiratory muscles
- moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake oxygen saturation of <92%
- psychiatric disease that limits the ability to give informed consent or complete the study
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 |
|---|---|---|
| Home sleep studyThe home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events | Device | Home sleep study |
| conventional polysomnographyconventional type I sleep study according to international guidelines | Device | Conventional polysomnography |
Primary outcome
Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment
Time frame: Baseline and 3 months
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought.
1 secondary outcome
Difference in Healthcare Costs Between Ambulatory and Hospital Approach
Time frame: within 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30795760Ng SS, Tam W, Chan TO, To KW, Ngai J, Chan KKP, Yip WH, Lo RL, Yiu K, Ko FW, Hui DS. Use of Berlin questionnaire in comparison to polysomnography and home sleep study in patients with obstructive sleep apnea. Respir Res. 2019 Feb 22;20(1):40. doi: 10.1186/s12931-019-1009-y.
- Individual participant dataSharing planned: Yes
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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.
David Hui, MD principal investigator
Chinese University 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 Home sleep study and conventional polysomnography 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 1 inclusion and 4 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 Mar 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. 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?
Yes. Results are posted in the registry (first posted 29 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment (time frame: Baseline and 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 NCT01828216, 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 Mar 2016.