Ambulatory Versus Conventional Approach Diagnosing OSA

Not Applicable

Completed

• Conditions: OSA
• Interventions: Device: conventional polysomnography; Device: Home sleep study

• Registration Number: NCT01828216
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-10
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2016-01-27
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-26
• Last Update Submitted: 2016-02-26
• Results First Posted: 2016-03-29
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional polysomnography	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.
Home sleep study	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

Name	Time	Method
Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment	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

Name	Time	Method
Difference in Healthcare Costs Between Ambulatory and Hospital Approach	within 24 months

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇨🇳 Hong Kong SAR, China