Novel Auto-continuous Positive Airway Pressure (CPAP) Validation

August 6, 2014 updated by: Fisher and Paykel Healthcare

A Study to Validate a Novel Auto Continuous Positive Airway Pressure Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Auto-CPAP devices change therapeutic pressure based on the needs of the patient. Algorithms differ from machine to machine. This single-blind randomised crossover trial aims to compare the efficacy of SPAP (a novel Auto-CPAP algorithm) to conventional CPAP.

Up to 50 patients will be recruited from an OSA population, aged over 18. Participants will consist of male and female patients diagnosed with moderate-severe OSA (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants, according to the protocol approved by the Northern X Region Ethics Committee, providing written informed consent will be enrolled into the study. Patients will be enrolled sequentially according to the randomisation list. Patients will be randomised to CPAP or SPAP.

The therapeutic pressure will be based on the most recent titration night of each patient. Comparisons between data will be made using a one-tailed t-test for non-inferiority of the SPAP algorithm compared with conventional CPAP therapy.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • Fisher and Paykel Healthcare Sleep Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous positive airway pressure (CPAP) device.
Standard CPAP therapy
Device: CPAP
Standard CPAP therapy
Experimental: Auto-CPAP device (SPAP).
Novel Auto-CPAP algorithm
Device: SPAP
Novel Auto-algorithm for Auto-CPAP device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AHI
Time Frame: one post study night (once PSG is scored)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 10, 2011

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

August 8, 2014

Last Update Submitted That Met QC Criteria

August 6, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPH-SA-10-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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