NCT00307424

Brief Summary

AutoCPAP would lead to better compliance than FixCPAP

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

August 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
Last Updated

March 28, 2006

Status Verified

August 1, 2004

First QC Date

March 27, 2006

Last Update Submit

March 27, 2006

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

  • To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.

  • To compare the clinical efficacy of auto-CPAP and fixed CPAP in terms of pressure level to abolish OSA, Epworth sleepiness scale and quality of life questionnaire.

  • To compare patient acceptance of the different type of treatment.

Interventions

AutoCPAPDEVICE
FixCPAPDEVICE

Eligibility Criteria

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

You may qualify if:

  • All subjects should be CPAP naïve.
  • OSA confirmed with sleep study
  • Presence of daytime symptoms with excessive daytime sleepiness
  • Age between 18 to 65
  • RDI greater than 30
  • Agreed to participate in trial with informed consent signed

You may not qualify if:

  • Patients not suitable to nasal CPAP because of facial abnormality leading to poor mask fitting.
  • Patients with known COPD with type II failure
  • Patients with known heart failure.
  • Patients with predominant central sleep apnea.
  • Patients need bilevel positive airway pressure ventilation.
  • Patients refusing to participate the trial.
  • Patients have difficulty to follow up regularly.
  • patients with untreated or under treatment of hypothyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North District Hospital

Hong Kong, China

Location

Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (1)

  • To KW, Chan WC, Choo KL, Lam WK, Wong KK, Hui DS. A randomized cross-over study of auto-continuous positive airway pressure versus fixed-continuous positive airway pressure in patients with obstructive sleep apnoea. Respirology. 2008 Jan;13(1):79-86. doi: 10.1111/j.1440-1843.2007.01138.x.

    PMID: 18197915DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • To K Wang, FHKCP

    Prince of Wales Hosptial

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 28, 2006

Study Start

August 1, 2004

Study Completion

June 1, 2005

Last Updated

March 28, 2006

Record last verified: 2004-08

Locations

CN(2)