Novel Auto-continuous Positive Airway Pressure (CPAP) Validation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: SPAP
* Device: CPAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |