Novel Auto-continuous Positive Airway Pressure (CPAP) Validation

NCT ID: NCT01943708

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-10-31

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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous positive airway pressure (CPAP) device.

Standard CPAP therapy

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: DEVICE

Standard CPAP therapy

Auto-CPAP device (SPAP).

Novel Auto-CPAP algorithm

Group Type: EXPERIMENTAL

SPAP

Intervention Type: DEVICE

Novel Auto-algorithm for Auto-CPAP device

Interventions

SPAP

Novel Auto-algorithm for Auto-CPAP device

Intervention Type: DEVICE

CPAP

Standard CPAP therapy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fisher and Paykel Healthcare Sleep Lab

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

FPH-SA-10-07

Identifier Type: -

Identifier Source: org_study_id