Ambulatory Versus Conventional Approach Diagnosing OSA

NCT01828216 | Completed Results

• 1 other identifier: amb_hosp_OSA
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

OSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Difference in Healthcare Costs Between Ambulatory and Hospital Approach

  within 24 months

Study Arms (2)

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.

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.

Device: Home sleep study

Interventions

Home sleep study DEVICE

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

Home sleep study

conventional polysomnography DEVICE

conventional type I sleep study according to international guidelines

Conventional polysomnography

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong SAR, China

Location

Related Publications (1)

• 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.

  PMID: 30795760 DERIVED

Results Point of Contact

• Title: David SC Hui
• Organization: Chinese University of Hong Kong

dschui@cuhk.edu.hk

852 2632 2211

Study Officials

• David Hui, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 10, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 29, 2016
• Results First Posted: March 29, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)