Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea

ConditionObstructive Sleep Apnea

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorZeus Sleep Ltd

About this trial

The objective of this trial is to assess efficacy and compliance of transcutaneous electrical stimulation of the upper airway dilator muscles in patients with obstructive sleep apnoea (TESLA) who do not tolerate continuous positive airway pressure (CPAP) therapy over a period of 3-months in the community and compare results against usual care (ongoing CPAP therapy), evaluate acceptability, comfort and adverse events, and record outcomes for provision of the health economics analysis. The proposed study will provide us with data about the efficacy of the domiciliary use of the intervention from a UK-based prospective, multi-centre and randomised controlled trial (Phase III). We will understand whether the primary outcome parameter, the apnoea hypopnea index (AHI), or the secondary outcomes (e.g. 4% oxygen desaturation index (ODI), the Epworth Sleepiness Scale (ESS), compliance and comfort, Functional Outcome of Sleep Questionnaires (FOSQ), European Quality of Life Questionnaire (EQ-5D)) are suitable measures to assess control of OSA using TESLA within reasonable acceptance for the patients to provide the analysis of healthcare resource usage for assessment of cost-efficacy and quality-adjusted life years (QALYs). Responder analysis will provide insights into gender, socio-economic background and endotypes to predict who most suitably benefits from this treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult participants (≥18 years) who have OSA with an AHI between 5-40 events/hour, as measured by the baseline sleep study (3 nights off CPAP).

If the participant fails to use CPAP sufficiently, defined as use of CPAP for less than 4 hours/night on fewer than 70% of nights over a minimum period of 3 months prior to enrolment.

Adults with a body mass index (BMI) of 18.5-32.0 kg/m2 (inclusive)

Adults without significant anatomical obstruction in the upper airway (e.g., normal sized tonsils).

Disqualifiers

Hypercapnic patients (pCO2>6.0 kPa) or those with other features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- >28mmol/L).

Adults with significantly enlarged tonsils (size 3-4)

Adults with polyps or adenoids, hypoglossal nerve palsy,

Adults with notable medical co-morbidities that could potentially impact participation in or the achievement of the study's objectives (e.g., significant heart failure (New York Heart Association, NYHA class III-IV), recent myocardial infarction (within 3 months) and significant cardiac arrhythmias, uncontrolled hypertension).

Trial design

Design model

Parallel

Treatments tested in this trial

ZeusOSA
Device
Transcutaneous electrical stimulation in sleep apnoea (TESLA) in the submittal area, provided by the ZeusSleep device when asleep.
CPAP
Device
Continous positive airway pressure (CPAP) when asleep

Treatment groups

186 Participants

are divided into 2 treatment groups

Group A: Usual CareActive comparator 1 intervention

Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Apnea-hypopnea-index (AHI)

Number of respiratory events per hour measured by home-based sleep study.

Time frame

Baseline to 3 months

Secondary outcomes

Epworth Sleepiness Scale (ESS)

Daytime sleepiness measured using the Epworth Sleepiness Scale (score range 0-24, with higher scores indicating greater sleepiness).

Time frame

Baseline to 3 months

EQ-5D Index Score

Health-related quality of life measured using the EQ-5D descriptive system (index score 0-1).

Time frame

Baseline to 3 months

EQ-5D Visual Analogue Scale (VAS) Score

Self-rated health measured using the EQ-5D visual analogue scale (0-100, with higher scores indicating better perceived health).

Time frame

Baseline to 3 months

Functional Outcome of Sleep Questionnaire (FOSQ-10) Score

Sleep-related functional status measured using the FOSQ-10, with higher scores indicating better functional outcomes.

Time frame

Baseline to 3 months

Other outcomes

SHER15 criteria defining responders to treatment

Reduction of AHI of more than 50% to below 15 events per hour, or normal (below 5 per hour);

Time frame

3-months

SHER20 criteria defining responders to treatment

Reduction of AHI of more than 50% to below 20 events per hour, or normal (below 5 per hour);

Time frame

3-months

Gender-related response

Responder rate according to gender (male vs female responders, percentage)

Time frame

3-months

Cost-Effectiveness

Cost-effectiveness of ZeusOSA compared to usual care (ongoing CPAP) in patients with low CPAP adherence, expressed as incremental cost-effectiveness ratios (ICERs). ICERs are a composite measure which will be derived from: proportion of responders, quality of life (EQ-5D-5L), and healthcare resource use/cost data.

Time frame

3 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zeus Sleep Ltd

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborator

King's College London

Collaborator

Royal Brompton & Harefield NHS Foundation Trust

Collaborator

Queen Victoria Hospital NHS Foundation Trust

Collaborator

The Queen Elizabeth Hospital

Collaborator

Imperial College Healthcare NHS Trust

Collaborator

AintreeNHSTrust

Collaborator

University of Southampton

Collaborator

Royal Papworth Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: