Domiciliary Transcutaneous Electrical Stimulation in Obstructive Sleep Apnoea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of
      the pharyngeal dilator muscles in patients with obstructive sleep apnoea in the community
      compared to usual care, and follow the patients for three months, as well as to assess
      compliance of non-invasive electrical stimulation of the upper airway dilator muscles in
      obstructive sleep apnoea patients over time and evaluate the control of symptoms and
      improvement in quality of life.
    

Detailed description: 
      Obstructive sleep apnoea is highly prevalent, with the obesity epidemic increasing the
      problem. The best treatment for uncomplicated and moderate-severe OSA remains CPAP therapy.
      However, long-term adherence to treatment with CPAP is poor and there are few alternatives.
      Electrical stimulation of the dilator muscles of the upper airway has been shown to reduce
      nocturnal apnoeas significantly using an invasive approach, hypoglossal nerve stimulation, as
      well as by non-invasive transcutaneous stimulation. Although non-invasive transcutaneous
      stimulation may not be as effective as CPAP therapy in many OSA patients it could be an
      important option to treat some of the large number of patients who fail CPAP and might also
      be of use in those whose OSA is not judged sufficiently severe to warrant CPAP.

      The investigators propose a study to use a transcutaneous electrical stimulation device in
      selected patients with OSA who do not tolerate CPAP therapy following assessment of the upper
      airway. Participants will undergo a baseline sleep study (polysomnography/home-based
      respiratory polygraphy). Following minimisation for gender (male/female) and OSA severity
      (mild/moderate-severe) they will be randomised into active treatment arm (transcutaneous
      electrical stimulation) or usual care (ongoing CPAP therapy). Patients will be treated over a
      period of 3-months in the community, re-assessed (including polysomnography/home-based
      respiratory polygraphy) and the results will be compared against usual care, ongoing CPAP
      therapy. This study will help to prepare a definitive multi-centre randomized controlled
      trial using the non-invasive method of upper airway stimulation in OSA.

      The primary aim of this study is to assess efficacy and generate an accurate sample size
      estimation, test the subjective willingness of patients to use and objectively determined
      compliance with the treatment over a long period, as well as to specify the drop-out rate.
      The improvement in sleep apnoea will be the primary outcome measures. The symptomatic
      response, feasibility of the method, including compliance, comfort, adverse events, will be
      the secondary outcome measure. An ad-hoc analysis will be performed in the responder group
      (improvement in the apnoea-hypopnea index (AHI) by >50% from baseline OR improvement in the
      4% oxygen-desaturation index (ODI) >25% from baseline OR AHI/4%ODI <5/hour at follow up).
    

Intervention name(s): Transcutaneous electrical stimulation; Continuous positive airway pressure
Intervention type(s): Device; Device
Intervention description(s): The device needs to be started by pressing the 'on' button. Once the device is turned on the current intensity can be increased by pushing the '+' button and lowered by pushing the '-' button. When a comfortable skin sensation is felt the patients should press the '-' button once more. At that time the device stimulates with a low current which is not felt but provides a neuromuscular tone to the muscles whilst asleep. The device is kept on all night and in the morning taken off with the hydrogel and disconnected. Once disconnected it should be turned off by pressing the 'off' button.; CPAP will be applied according to usual clinical care, the follow up will be organised in the same way as the active intervention group.
Other intervention name(s): TESLA home; CPAP (usual care)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised parallel group controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: upper airway; genioglossus; CPAP; electrical stimulation; sleep; sleep disordered breathing