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Ambulatory Versus Conventional Approach Diagnosing OSA

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ClinicalTrials.gov Identifier: NCT01828216
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Prof David Shu Cheong Hui, Chinese University of Hong Kong

Brief 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). 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.

Condition or disease Intervention/treatment Phase
OSA Device: Home sleep study Device: conventional polysomnography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Study Assessing the Role of an Ambulatory Approach Versus the Conventional Approach in Managing Suspected Obstructive Sleep Apnoea Syndrome
Study Start Date : January 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional polysomnography
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.
Device: conventional polysomnography
conventional type I sleep study according to international guidelines

Active Comparator: Home sleep study
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.
Device: Home sleep study
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Difference in Healthcare Costs Between Ambulatory and Hospital Approach [ Time Frame: within 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptoms of OSA with home sleep study AHI >= 15/hr.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828216


Locations
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China
The Chinese University of Hong Kong
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: David Hui, MD Chinese University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof David Shu Cheong Hui, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01828216    
Other Study ID Numbers: amb_hosp_OSA
First Posted: April 10, 2013    Key Record Dates
Results First Posted: March 29, 2016
Last Update Posted: March 29, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes