Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea - Full Text View

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00425659

Purpose

Newer home sleep study device and algorithm provides an alternative for inpatient sleep study and improve the service provides to patients

Condition	Intervention
Sleep Apnea	Device: home sleep study Device: home CPAP titration (Autoset) Device: CPAP

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea in High Risk Population in Hong Kong

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Validity of the new home sleep study device compare with conventional inpatient sleep study [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The relative efficacy between different algorithm [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Failure rates in different algorithms which need to switch to the conventional algorithm [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2007
Study Completion Date:	June 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
3: Active Comparator	Device: home CPAP titration (Autoset) continuous positive airway pressure device for treatment of sleep apnea
1: Experimental	Device: home sleep study different in algorithm arrangement for diagnosing sleep apnea
2 usual practice	Device: CPAP usual practice

Detailed Description:

Purpose: Assess different potential algorithms to improve the service and cost utility for diagnosis and treatment of obstructive sleep apnea syndrome (OSAS) in patients with high pretest probability in Hong Kong. Hypothesis: Newer home sleep study device and algorithm provides an alternative for inpatient sleep study Design: Prospective randomized study Subject: High pretest probability of OSAS patients referred to a tertiary centre.

Study instruments: a portable sleep study device, AutoCPAP and inpatient sleep monitoring system.

Interventions: comparison between 3 different algorithms of health service for OSA patients would be made:

conventional in-patient sleep study, empirical treatment and home sleep study. Main outcome measures: The primary outcome is the validity of the home sleep study device compare to inpatient sleep study. The secondary outcomes are the relative efficacy of different algorithms and the numbers of failed procedures in each algorithm.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients with high pretest probability of OSAS, i.e. ESS > 10 or symptomatic patients, with BMI > 23 and/or cranial facial features associated with OSA, as assessed by the attending respiratory physician in the respiratory clinic.
Patients aged between 18-65 years who agree to participate in the study.

Exclusion Criteria:

Pregnant women
Patients who refuse signing consent of the study
Do not have high pretest probability of OSAS
Refuse to have home sleep study
Refuse any treatment offered; or
Could not comply with the set up of home study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425659

Locations

China
The Chinese University of Hong Kong
Hong Kong, China

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

Kin W To, MBChB

Chinese University of Hong Kong

More Information

No publications provided

Responsible Party:	CUHK ( Doctor )
Study ID Numbers:	CRE-2006.404-T
Study First Received:	January 22, 2007
Last Updated:	July 9, 2009
ClinicalTrials.gov Identifier:	NCT00425659 History of Changes
Health Authority:	Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:

Health utility
Home sleep study

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Nervous System Diseases
Respiration Disorders

Sleep Apnea, Obstructive
Sleep Disorders
Dyssomnias
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on September 02, 2009