NCT00425659

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

2.2 years

First QC Date

January 22, 2007

Last Update Submit

July 9, 2009

Conditions

Sleep Apnea

Keywords

Health utilityHome sleep study

Outcome Measures

Primary Outcomes (1)

  • Validity of the new home sleep study device compare with conventional inpatient sleep study

    1 year

Secondary Outcomes (2)

  • The relative efficacy between different algorithm

    1 year

  • Failure rates in different algorithms which need to switch to the conventional algorithm

    1 year

Study Arms (3)

3

ACTIVE COMPARATOR
Device: home CPAP titration (Autoset)

1

EXPERIMENTAL
Device: home sleep study

2

OTHER

usual practice

Device: CPAP

Interventions

home sleep studyDEVICE

different in algorithm arrangement for diagnosing sleep apnea

Also known as: different algorithm arrangement
1
home CPAP titration (Autoset)DEVICE

continuous positive airway pressure device for treatment of sleep apnea

Also known as: Autoset
3
CPAPDEVICE

usual practice

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Kin W To, MBChB

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2007

First Posted

January 23, 2007

Study Start

January 1, 2007

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations

CN(1)