Continuous Transcutaneous Electrical Stimulation in Sleep Apnoea

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnoea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Transcutaneous electrical stimulation

One night of transcutaneous electrical stimulation (electrical current titrated according to skin sensation)

Group Type ACTIVE_COMPARATOR

Transcutaneous electrical stimulation

Intervention Type DEVICE

Transcutaneous electrical stimulation (one night of electrical current titrated according to skin sensation)

Sham stimulation

One night of sham stimulation (no electrical current)

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

Sham stimulation for one night (no electrical stimulation)

Interventions

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Transcutaneous electrical stimulation

Transcutaneous electrical stimulation (one night of electrical current titrated according to skin sensation)

Intervention Type DEVICE

Sham stimulation

Sham stimulation for one night (no electrical stimulation)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* males and females, age \>18years and \<75years, body-mass index (BMI) \>18 and \<40kg/m2, non-smokers, sleep apnoea with an ODI ≥15/h or sleep apnoea with an ODI ≥5/h plus an Epworth sleepiness score \>10.

Exclusion Criteria

* morbid obesity (BMI\>40kg/m2) or cachexia (BMI\<18kg/m2), obesity-hypoventilation syndrome (total sleep time with oxygen saturation (SpO2) less than 90% of more than 10% of the night), active smokers or smoking history of \>20pack years, acute or critical illness, acute psychosis or chronic mental disorder affecting capacity, previous home-mechanical non-invasive ventilation and metal implants in the upper part of the body (this excludes dental implants).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No