NCT00739011

Brief Summary

This study is designed to determine the effectiveness of two different CPAP devices. One a standard CPAP which has the ability to store comprehensive compliance and efficacy data and the second a auto adjusting CPAP which uses the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 9, 2008

Status Verified

December 1, 2008

Enrollment Period

3 months

First QC Date

August 19, 2008

Last Update Submit

December 7, 2008

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

  • Apnea Hypopnea Index (AHI)

    At the end of the sleep study

Study Arms (1)

1

EXPERIMENTAL
Device: SleepStyle 254/244 CPAP series CPAP humidifier

Interventions

SleepStyle 254/244 CPAP series CPAP humidifierDEVICE

Therapeutic CPAP pressure will be determined for individual subjects during the titration portion of an overnight sleep study. This pressure will range from 4 to 20 cmH20

1

Eligibility Criteria

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

You may not qualify if:

  • Significant Central Apnea
  • CHF
  • Co-existing obesity related hypoventilation
  • Inability to give informed consent
  • Patient intolerance to CPAP
  • Anatomical or physiological conditions making CPAP therapy inappropriate.
  • Less than 3 hours in the titration period
  • Under Land Transport New Zealand (LTNZ) investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Auckland Hospital Sleep laboratory

Auckland, New Zealand

Location

Auckland Physiology Sleep Lab

Auckland, New Zealand

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jessica Hayward, MSc

    Fisher and Paykel Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 21, 2008

Study Start

August 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 9, 2008

Record last verified: 2008-12

Locations

NZ(2)