NCT01943708

Brief Summary

This single-blind randomised crossover trial aims to compare the efficacy of a novel Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an OSA population, aged over 18.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2010

Typical duration for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2011

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

August 8, 2014

Status Verified

August 1, 2014

Enrollment Period

3.1 years

First QC Date

July 10, 2011

Last Update Submit

August 6, 2014

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

  • AHI

    The apnea hypopnea index (AHI) is a measure of sleep disordered breathing. It will be measured and compared between the two groups. The units are number of events per hour.

    one post study night (once PSG is scored)

Study Arms (2)

Continuous positive airway pressure (CPAP) device.

ACTIVE COMPARATOR

Standard CPAP therapy

Device: CPAP

Auto-CPAP device (SPAP).

EXPERIMENTAL

Novel Auto-CPAP algorithm

Device: SPAP

Interventions

SPAPDEVICE

Novel Auto-algorithm for Auto-CPAP device

Auto-CPAP device (SPAP).
CPAPDEVICE

Standard CPAP therapy

Continuous positive airway pressure (CPAP) device.

Eligibility Criteria

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

You may qualify if:

  • Aged ≥18 years with mild-to-severe OSA (Apnea Hypopnea Index equal to or greater than 5 per hour).

You may not qualify if:

  • Any medical condition which contraindicates (see Appendix A) the use of CPAP or AutoCPAP.
  • Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
  • Unstable psychiatric disease.
  • Other significant sleep disorder.
  • Inability to tolerate CPAP due to nasal obstruction or claustrophobia, as determined by the investigation investigator.
  • Any known factor or disease that might interfere with treatment compliance, investigation conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with investigational requirements.
  • Participation in another clinical trial in the previous month.
  • Less than 2 hours recorded sleep in either arm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisher and Paykel Healthcare 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 Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2011

First Posted

September 17, 2013

Study Start

September 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

August 8, 2014

Record last verified: 2014-08

Locations

NZ(1)