Ambulatory Versus Conventional Approach Diagnosing OSA

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.

Study Overview

• Status: Completed
• Conditions: OSA
• Intervention / Treatment: Device: conventional polysomnography; Device: Home sleep study

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 Type: Interventional
• Enrollment (Actual): 316
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong SAR, China
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in Healthcare Costs Between Ambulatory and Hospital Approach	within 24 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: David Hui, MD, Chinese University of Hong Kong

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: April 8, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (ESTIMATE): April 10, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 29, 2016
• Last Update Submitted That Met QC Criteria: February 26, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: amb_hosp_OSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES