Nexus Compliance Study
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

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.
    

Intervention name(s): CPAP Pre Nexus (S9); Nexus (S9); CPAP Post Nexus (S9)
Intervention type(s): Device; Device; Device
Intervention description(s): 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); 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.; 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 intervention name(s): Patient's own CPAP; S9 AutoSet; Patient's own CPAP
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPAP compliance