Back to resultsNovel Auto-continuous Positive Airway Pressure (CPAP) Validation
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Phase 3
Locations
New Zealand
Study Type
Interventional
Intervention
SPAP
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive
Eligibility Criteria
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
Sites / Locations
- Fisher and Paykel Healthcare Sleep Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Continuous positive airway pressure (CPAP) device.
Auto-CPAP device (SPAP).
Arm Description
Standard CPAP therapy
Novel Auto-CPAP algorithm
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01943708
First Posted
July 10, 2011
Last Updated
August 6, 2014
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT01943708
Brief Title
Novel Auto-continuous Positive Airway Pressure (CPAP) Validation
Official Title
A Study to Validate a Novel Auto Continuous Positive Airway Pressure Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous positive airway pressure (CPAP) device.
Arm Type
Active Comparator
Arm Description
Standard CPAP therapy
Arm Title
Auto-CPAP device (SPAP).
Arm Type
Experimental
Arm Description
Novel Auto-CPAP algorithm
Intervention Type
Device
Intervention Name(s)
SPAP
Intervention Description
Novel Auto-algorithm for Auto-CPAP device
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Standard CPAP therapy
Primary Outcome Measure Information:
Title
AHI
Description
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.
Time Frame
one post study night (once PSG is scored)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fisher and Paykel Healthcare Sleep Lab
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
Novel Auto-continuous Positive Airway Pressure (CPAP) Validation
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