Ambulatory Versus Conventional Approach Diagnosing OSA

NCT ID: NCT01828216

Last Updated: 2016-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-09-30

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.

Conditions

OSA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

conventional polysomnography

Intervention Type: DEVICE

conventional type I sleep study according to international guidelines

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.

Group Type: ACTIVE_COMPARATOR

Home sleep study

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

conventional polysomnography

conventional type I sleep study according to international guidelines

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof David Shu Cheong Hui

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Hui, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Hong Kong SAR, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 30795760 (View on PubMed)

Other Identifiers

amb_hosp_OSA

Identifier Type: -

Identifier Source: org_study_id