N/A
N=50
Nexus Compliance Study
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01013207 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: Compliance on CPAP — 6.58; 7.07; 6.72 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPAP Pre Nexus (S9) (Device); Nexus (S9) (Device); CPAP Post Nexus (S9) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compliance on CPAP |
6.58; 7.07; 6.72 | — |
| SECONDARY Usability of the Nexus (S9) CPAP. |
9.48 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01013207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.