Clinical trial NCT01013207: Nexus Compliance Study
Official title: Assessment of the Compliance and Usability of the Nexus (S9) CPAP System in Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: CPAP compliance
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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

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 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

Primary outcomes:
measure: Compliance on CPAP
timeFrame: 12 weeks
Secondary outcomes:
measure: Usability of the Nexus (S9) CPAP.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: ResMed Sleep Reseach Centre
state: New South Wales
Study officials:
affiliation: ResMed
name: Klaus Schindhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wimms AJ, Richards GN, Benjafield AV. Assessment of the impact on compliance of a new CPAP system in obstructive sleep apnea. Sleep Breath. 2013 Mar;17(1):69-76. doi: 10.1007/s11325-012-0651-0.