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

Summary: 
      The aim of this randomized, double-blinded, sham-controlled cross-over trial is to
      demonstrate the effectiveness of continuous transcutaneous electrical stimulation of the
      pharyngeal dilator muscles to reduce sleep-disordered breathing.
    

Detailed description: 
      Obstructive sleep apnoea is the most common problem of sleep-disordered breathing. It affects
      at least four percent of the male and two percent of the female adult population. It is
      associated with excessive daytime sleepiness, causing significant disturbance of daytime
      routines affecting work, social life and memory; untreated, it also causes a significant
      cardiovascular and metabolic risk. The best available treatment for obstructive sleep apnoea
      is continuous positive airway pressure (CPAP). However, not everyone eligible tolerates this
      treatment because it requires them to sleep with a nasal or full-face mask that is connected
      by a tube to a machine. Although CPAP is recommended by the National Institute for Health and
      Clinical Excellence (NICE) for moderate-severe sleep apnoea, approximately one third of sleep
      apnoea patients who should be on CPAP stop therapy within five years. Mild sleep apnoea is
      currently treated with mandibular advancement splints and generic sleep hygiene advice.

      Continuous transcutaneous electrical stimulation (CTES) of the submental region activates the
      muscles that dilate the upper airway. This is where airway obstruction occurs in sleep
      apnoea. It has been shown that CTES at night for short periods (10minutes) effectively
      stimulates the genioglossus muscle, the strongest pharyngeal dilator and reduces upper airway
      obstruction, work of breathing and neural respiratory drive in patients with sleep apnoea.
      The London Respiratory Muscle Groups, based within King's Health Partners and the Royal
      Brompton Hospital, has developed a CTES stimulator device. This device senses apnoeas and
      snoring and delivers CTES until normal ventilation has been restored.

      We propose to undertake a randomized, double-blinded, sham-controlled cross-over trial with
      sleep apnoea patients to evaluate the efficacy of this method. Patients will be randomly
      assigned to a night of CTES or sham-stimulation. The primary outcome measure is the number of
      oxygen desaturations per hour (ODI) caused by apnoeas and the secondary outcome measures are
      sleepiness, as measured by the Epworth sleepiness score, the apnoea-hypopnoea-index (AHI) and
      comfort, as assessed by a visual analogue score. The sample size Calculation using data from
      our own published pilot study revealed that this study would require 44 patients to be
      enroled. The mean study duration until all outcomes will be assessed for each patient will be
      four weeks. We plan to commence the study in winter 2012/13 for a period of two years,
      including analysis and publication, to be concluded in December 2014.
    

Intervention name(s): Transcutaneous electrical stimulation; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Transcutaneous electrical stimulation (one night of electrical current titrated according to skin sensation); Sham stimulation for one night (no electrical stimulation)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obstructive sleep apnoea,; continuous transcutaneous electrical stimulation