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Nexus Compliance Study

This study has been completed.
Sponsor:
Information provided by:
ResMed
ClinicalTrials.gov Identifier:
NCT01013207
First received: November 11, 2009
Last updated: September 1, 2010
Last verified: September 2010
History of Changes
  Purpose

Obstructive sleep apnoea (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 positive airway pressure to the upper airway via a tube and mask. Humidification is used during CPAP therapy to improve the comfort of the delivered air and to alleviate nasal dryness/congestion.

The latest design of a CPAP device, known as Nexus (S9), encompasses new features including an improved humidification system (heated tube and climate control), reduced noise, improved comfort of breathing, and a new user interface.

This study will assess whether compliance on CPAP therapy is improved on the Nexus (S9) CPAP, and will assess the usability of the Nexus (S9) CPAP


Condition Intervention
Obstructive Sleep Apnea
 Device: CPAP Pre Nexus (S9)
Device: Nexus (S9)
Device: CPAP Post Nexus (S9)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Compliance and Usability of the Nexus (S9) CPAP System in Sleep Disordered Breathing

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by ResMed:

Primary Outcome Measures:
  • Compliance on CPAP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Compliance on CPAP was measured as average daily usage


Secondary Outcome Measures:
  • Usability of the Nexus (S9) CPAP. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The usability quesitonnaire was administered at the end of the 4 week trial of Nexus (S9). Usability was defined as ease of using the Nexus (S9) and overall satisfaction with the Nexus (S9) CPAP. The outcome measure was collected through 11 point Likert questionnaires, where 0 = very poor usability and 10 = excellent usability.


Enrollment: 50
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nexus (S9) CPAP device

Fifty subjects with obstructive sleep apnea (OSA), established on CPAP therapy (≥ 6 months) were recruited into this study. These patients use their CPAP device every night while sleeping to treat their OSA.

Nexus (S9) is a new CPAP device with improved humidification system (heated tube and climate control), reduced noise, improved comfort of breathing and new user interface. During the study, patients will use this CPAP every night in place of their own CPAP for a period of 4 weeks. Compliance data from the Nexus will then be compared to the patient's usual CPAP pre trialling Nexus and post trialling Nexus.

 Device: CPAP Pre Nexus (S9)
This is the patient's own CPAP prior to trialling the Nexus (S9). 4 weeks of data will be downloaded from this device and compared to 4 weeks using Nexus (S9), and 4 weeks usage post trialling Nexus (S9)
Other Name: Patient's own CPAP
Device: Nexus (S9)
The patient will use the new Nexus (S9) CPAP for four weeks in place of their usual CPAP every night when they sleep to treat their OSA. Compliance data will be compared between four weeks on this device to the last four weeks on their current device (CPAP Pre S9). After using the Nexus (S9) CPAP for four weeks, participants will return to their current device for four weeks. Data from this post-trial period will be compared with both the Nexus (S9) four weeks, and the four weeks pre Nexus (S9) usage.
Other Name: S9 AutoSet
Device: CPAP Post Nexus (S9)
After trialling the Nexus (S9) for four weeks, patients will return to their usual CPAP. Data from the patient's usual CPAP for four weeks will be compared to data while using the Nexus (S9), and data from the patient's usual device pre trialling S9 (CPAP Pre Nexus)
Other Name: Patient's own CPAP

Detailed Description:

Obstructive Sleep Apnoea (OSA) is a condition characterised by the partial or complete collapse of the upper airway during sleep. OSA comprises a continuous spectrum of severity ranging from simple snoring and upper airway resistance through mild to severe symptomatic obstructive hypopnoea and apnoea. The prevalence of sleep disordered breathing in the adult population is 24% males and 9% for females. The prevalence of symptomatic OSA in the adult population has been estimated to be 4% in males and 2% in females. These patients demonstrate behavioural and neuropsychological consequences to varying degrees, including excessive daytime sleepiness, intellectual deterioration and depression. More serious consequences include arterial systemic hypertension, arterial pulmonary hypertension and heart disease.

The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Humidification is used during CPAP therapy to improve comfort of the delivered air and alleviate nasal dryness/congestion.

Compliance with CPAP is a known issue which is affected by many things, including negative side effects and issues with the equipment. The most common complaints involve nasal dryness/congestion and noise from the machine.

The purpose of this study is to assess whether the improved humidification system, reduced noise, improved comfort of breathing and new user interface on the Nexus (S9) CPAP will improve compliance.

Aims:

  1. To determine if compliance on the new Nexus (S9) CPAP is improved over the patient's usual CPAP
  2. To assess the usability of the Nexus (S9) CPAP.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willingness to provide written informed consent
  • Patients who are using a ResMed mask system
  • Patients who are at least 18 years of age
  • Patients who use a ResMed CPAP device

Exclusion Criteria:

  • Patients currently using Bilevel PAP
  • Patients who are pregnant

  • Patients who the researcher believes are unsuitable for inclusion because either:

    • they do not comprehend English
    • they are unable to provide written informed consent
    • they are physically unable to comply with the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013207

Locations
Australia, New South Wales
ResMed Sleep Reseach Centre
Sydney, New South Wales, Australia, 2153
Sponsors and Collaborators
ResMed
Investigators
Principal Investigator: Klaus Schindhelm, PhD ResMed
  More Information

No publications provided by ResMed

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Klaus Schindhelm: Professor, Graduate School of Biomedical Engineering, UNSW, ResMed
ClinicalTrials.gov Identifier: NCT01013207     History of Changes
Other Study ID Numbers: MA051109
Study First Received: November 11, 2009
Results First Received: July 12, 2010
Last Updated: September 1, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by ResMed:
CPAP compliance

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013