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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906958
• Other study ID #: 08177-0608
• Status: Completed
• Phase: N/A
• Start date: May 11, 2009
• Est. completion date: June 15, 2009

Study information

• Verified date: February 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00773396

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 15, 2009
• Est. primary completion date: June 15, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• Nexus 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.
• VPAP Flow Generator 25
Exiting VPAP Auto 25 Flow Generator with A10 Algorithm

Locations

Country	Name	City	State
Australia	Centre for Healthy Sleep	Bella Vista	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnoea-Hypopnoea Index (AHI)	The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto & VPAP Auto 25	One Night On Each Arm, approximately 8 hours each night
Primary	Oxygen Desaturation Index	Number of oxygen desaturations per hour of sleep	One Night On Each Arm, approximately 8 hours each night
Secondary	Comfort of Breathing	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	One Night On Each Arm, approximately 8 hours each night
Secondary	Satisfaction of Treatment	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	One Night On Each Arm, approximately 8 hours each night
Secondary	Refreshed Feel	Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning?	One Night On Each Arm, approximately 8 hours each night