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

NCT00906958 | Completed Results

• 1 other identifier: 08177-0608
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• 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

• Oxygen Desaturation Index

  Number of oxygen desaturations per hour of sleep

  One Night On Each Arm, approximately 8 hours each night

Secondary Outcomes (3)

• 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

Study Arms (2)

Nexus Flow Generator

EXPERIMENTAL

Participants were randomised to Nexus Flow Generator group for one night.

Device: Nexus Flow Generator

VPAP Flow Generator 25

ACTIVE COMPARATOR

Participants were randomised to VPAP Flow Generator 25 group for one night.

Device: VPAP Flow Generator 25

Interventions

Nexus Flow Generator DEVICE

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.

Nexus Flow Generator

VPAP Flow Generator 25 DEVICE

Exiting VPAP Auto 25 Flow Generator with A10 Algorithm

VPAP Flow Generator 25

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Centre for Healthy Sleep

Bella Vista, New South Wales, 2135, Australia

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Alison Wimms
• Organization: ResMed Ltd

alison.wimms@resmed.com

+44 7901332675

Study Officials

• Klaus Schindhelm, PhD

  ResMed/The University of New South Wales

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 21, 2009
• Study Start: May 11, 2009
• Primary Completion: June 15, 2009
• Study Completion: June 15, 2009
• Last Updated: March 22, 2021
• Results First Posted: March 22, 2021

Record last verified: 2021-02

Locations

AU (1)