Novel Auto-continuous Positive Airway Pressure (CPAP) Validation

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943708
• Other study ID #: FPH-SA-10-07
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2011
• Last updated: August 6, 2014
• Start date: September 2010
• Est. completion date: October 2013

Study information

• Verified date: August 2014
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

Device:
• SPAP
Novel Auto-algorithm for Auto-CPAP device
• CPAP
Standard CPAP therapy

Locations

Country	Name	City	State
New Zealand	Fisher and Paykel Healthcare Sleep Lab	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No