Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Nexus Flow Generator	Nexus Flow Generator	Participants were randomised to Nexus Flow Generator group for one night.
VPAP Flow Generator 25	VPAP Flow Generator 25	Participants were randomised to VPAP Flow Generator 25 group for one night.

Primary Outcome Measures

Name	Time	Method
Oxygen Desaturation Index	One Night On Each Arm, approximately 8 hours each night	Number of oxygen desaturations per hour of sleep
Apnoea-Hypopnoea Index (AHI)	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 Outcome Measures

Name	Time	Method
Satisfaction of Treatment	One Night On Each Arm, approximately 8 hours each night	Participant's treatment satisfaction in one question: How much did the CPAP disturb your sleep last night? Rating from 0 (a lot) to 10 (not at all) on a Likert Scale
Refreshed Feel	One Night On Each Arm, approximately 8 hours each night	Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning?
Comfort of Breathing	One Night On Each Arm, approximately 8 hours each night	Participant's Comfort Rating in one question: How comfortable/uncomfortable was the CPAP device to breathe on? Ratings from 0 (very uncomfortable) to 10 (very comfortable) on a Likert Scale