Comparison of the Efficacy and Subjective Comfort of a Modified AutoSet Device With an Existing AutoSet Device (VPAP Auto) in Treating Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Oxygen Desaturation Index
Study Overview
Brief Summary
The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.
Detailed Description
Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18-80 years
- •Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
- •Patients who are using ResMed masks
Exclusion Criteria
- •Patients who are unable to provide written informed consent
- •Patients who are unable to comprehend written and spoken English
- •Patients who are using Bilevel PAP
- •Patients who are pregnant
- •Patients who are suffering any of the following:
- •Acute respiratory infection
- •Acute sinusitis, otitis media or perforated eardrum
- •Pneumothorax or pneumomediastinum
- •Recent history of severe epistaxis requiring medical attention
Arms & Interventions
Nexus Flow Generator
Participants were randomised to Nexus Flow Generator group for one night.
Intervention: Nexus Flow Generator (Device)
VPAP Flow Generator 25
Participants were randomised to VPAP Flow Generator 25 group for one night.
Intervention: VPAP Flow Generator 25 (Device)
Outcomes
Primary Outcomes
Oxygen Desaturation Index
Time Frame: One Night On Each Arm, approximately 8 hours each night
Number of oxygen desaturations per hour of sleep
Apnoea-Hypopnoea Index (AHI)
Time Frame: One Night On Each Arm, approximately 8 hours each night
The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto \& VPAP Auto 25
Secondary Outcomes
- Comfort of Breathing(One Night On Each Arm, approximately 8 hours each night)
- Satisfaction of Treatment(One Night On Each Arm, approximately 8 hours each night)
- Refreshed Feel(One Night On Each Arm, approximately 8 hours each night)