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

Comparison of the Efficacy and Subjective Comfort of a Modified AutoSet Device With an Existing AutoSet Device (VPAP Auto) in Treating Obstructive Sleep Apnea

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00906958

Enrollment

Registered

2009-05-21

Start date

2009-05-11

Completion date

2009-06-15

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

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.

Interventions

DEVICENexus Flow Generator

The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.

DEVICEVPAP Flow Generator 25

Exiting VPAP Auto 25 Flow Generator with A10 Algorithm

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
Oxygen Desaturation Index	One Night On Each Arm, approximately 8 hours each night	Number of oxygen desaturations per hour of sleep

Secondary

Measure	Time frame	Description
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
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?

Countries

Australia

Participant flow

Participants by arm

Arm	Count
All Study Participants This was a cross-over study, therefore all participants were assigned to both interventions, for one night each, in a randomised order	20
Total	20

Baseline characteristics

Characteristic	All Study Participants
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	20 Participants
Region of Enrollment Australia	20 participants
Sex: Female, Male Female	17 Participants
Sex: Female, Male Male	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 20
other Total, other adverse events	0 / 20	0 / 20
serious Total, serious adverse events	0 / 20	0 / 20

Outcome results

Primary