Estimulación Eléctrica Transcutánea en Pacientes con Apnea Obstructiva del Sueño (TESLA-MICRON)
Zeus Sleep Technology: Un Ensayo Controlado Aleatorizado Multicéntrico Basado en el Reino Unido que Utiliza Estimulación Eléctrica Transcutánea en Pacientes con Apnea Obstructiva del Sueño (TESLA)
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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
The TESLA-MICRON study is a UK-based, prospective, multi-centre, randomised controlled trial designed to evaluate the use of an investigational medical device, ZeusOSA, for the treatment of obstructive sleep apnoea in adults with poor adherence to continuous positive airway pressure (CPAP) therapy.
ZeusOSA uses gentle stimulation through the skin similar to that of a TENS machine. The device features a U-shaped lightweight silicone pad with a disposable adhesive hydrogel electrode pad (single-use) that delivers mild transcutaneous electrical nerve stimulation (TENS) to activate the hypoglossal nerve, thereby stimulating muscles to contract, particularly those associated with opening the airways (e.g., genioglossus muscle). Application of regular electrical pulses to these muscles help to maintain an open airway. The upper airway muscles might otherwise relax with sleep onset and cause vibrations and collapse in the throat whilst breathing, manifesting as snoring or sleep apnoea's or hypopneas. The stimulation level is customisable from level 1 (milder stimulation) to level 10 (stronger stimulation).
186 participants will be recruited with a prior diagnosis of obstructive sleep apnoea and low CPAP adherence at follow up (less than 4 hours/night) will be randomly assigned in a 1:1 ratio to either the intervention group or a usual care group. Recruitment will focus on a balanced ratio of men and women, as women are typically under-represented in studies of OSA and, due to a slim neck / collar size in comparison to men, likely to be responders to the TESLA treatment. Participants allocated to the intervention group will use the investigational medical device, ZeusOSA, which delivers transcutaneous electrical stimulation to the upper airway dilator muscles during sleep. The device is intended for nightly use at home over a three-month period. Participants in the usual care group will continue with ongoing CPAP therapy in accordance with current clinical practice.
All participants will undergo baseline assessments prior to randomisation, including a home-based sleep study conducted without treatment. Follow-up will include a scheduled telephone contact at approximately six weeks and a repeat assessment at three months, including a further home-based sleep study conducted with the assigned treatment and receive standard advice on sleep hygiene and lifestyle measures. The patients will then be referred for follow up to standard care in the outpatient setting at their respective sleep centre. The trial duration including recruitment is 3 years.
The study will assess the therapeutic effects of the investigational medical device on sleep-related outcomes and symptoms, as well as participant-reported quality of life. Additional objectives include evaluation of treatment adherence, comfort and acceptability of use, and monitoring of adverse events. Data collected during the study will also be used to support an assessment of healthcare resource use associated with the intervention.
The study is designed to reflect real-world use of the investigational medical device in a domiciliary setting and to identify patient characteristics associated with response to treatment. Results from this trial will inform the future clinical and regulatory development of the device for the management of obstructive sleep apnoea.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Nigel Clarke, CEO
- Número de teléfono: x83435 +442071883434
- Correo electrónico: support@zeussleeps.com
Copia de seguridad de contactos de estudio
- Nombre: Salma Ayyis, PhD
- Número de teléfono: x82821 +442071882823
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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).
- Able and willing to provide informed written consent.
- Access to a smartphone and internet at home.
Exclusion Criteria:
- 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).
- Participants with an active psychiatric condition that, in the opinion of the Investigator, may affect the participant's capacity to provide informed consent, adhere to study procedures, actively participate in the study, or compromise the integrity of study data.
- Participants with active implantable medical devices, including but not limited to cardiac pacemakers, implantable cardioverter defibrillators (ICDs), cochlear implants, deep brain stimulation (DBS) systems, vagus nerve stimulation (VNS) devices, neurostimulators, or implanted infusion pumps.
- Participants with metallic implants in the head or neck region that, in the opinion of the Investigator, may interfere with the safe use of the investigational device.
- Participants who are physically incapacitated such as to manoeuvre the ZeusOSA device
- Adults with long facial hair that interferes with the correct placement of the hydrogel pad, and who are unwilling to shave.
- Participants with an allergy to plasters or similar products.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Comparador activo: Usual Care
Continuous Positive Airway Pressure (CPAP) |
Continous positive airway pressure (CPAP) when asleep |
|
Experimental: Intervention
Transcutaneous Electrical Stimulation (ZeusOSA) |
Transcutaneous electrical stimulation in sleep apnoea (TESLA) in the submittal area, provided by the ZeusSleep device when asleep. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Apnea-hypopnea-index (AHI)
Periodo de tiempo: Baseline to 3 months
|
Number of respiratory events per hour measured by home-based sleep study. |
Baseline to 3 months
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Epworth Sleepiness Scale (ESS)
Periodo de tiempo: Baseline to 3 months
|
Daytime sleepiness measured using the Epworth Sleepiness Scale (score range 0-24, with higher scores indicating greater sleepiness). |
Baseline to 3 months
|
|
EQ-5D Index Score
Periodo de tiempo: Baseline to 3 months
|
Health-related quality of life measured using the EQ-5D descriptive system (index score 0-1). |
Baseline to 3 months
|
|
EQ-5D Visual Analogue Scale (VAS) Score
Periodo de tiempo: Baseline to 3 months
|
Self-rated health measured using the EQ-5D visual analogue scale (0-100, with higher scores indicating better perceived health). |
Baseline to 3 months
|
|
Functional Outcome of Sleep Questionnaire (FOSQ-10) Score
Periodo de tiempo: Baseline to 3 months
|
Sleep-related functional status measured using the FOSQ-10, with higher scores indicating better functional outcomes. |
Baseline to 3 months
|
|
Snoring Duration
Periodo de tiempo: Baseline to 3 months
|
Total duration of snoring measured during sleep, expressed in minutes. |
Baseline to 3 months
|
|
Snoring Intensity
Periodo de tiempo: Baseline to 3 months
|
Average snoring intensity measured in decibels during sleep. |
Baseline to 3 months
|
|
Adherence Average hours/night
Periodo de tiempo: Baseline to 3 months
|
Average nightly usage (hours) of the assigned treatment. |
Baseline to 3 months
|
|
Adherence - Percentage of Nights Used
Periodo de tiempo: Baseline to 3 months
|
Percentage of nights the assigned treatment was used during the study period. |
Baseline to 3 months
|
|
4% ODI (Oxygen Desaturation Index)
Periodo de tiempo: Baseline to 3 months
|
ODI refers to the average number of desaturation episodes occurring per hour, where desaturation episodes are defined as a decrease in the mean oxygen saturation of ≥ 4% (over the last 120 seconds) that lasts for at least 10 seconds. |
Baseline to 3 months
|
Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SHER15 criteria defining responders to treatment
Periodo de tiempo: 3-months
|
Reduction of AHI of more than 50% to below 15 events per hour, or normal (below 5 per hour); |
3-months
|
|
SHER20 criteria defining responders to treatment
Periodo de tiempo: 3-months
|
Reduction of AHI of more than 50% to below 20 events per hour, or normal (below 5 per hour); |
3-months
|
|
Gender-related response
Periodo de tiempo: 3-months
|
Responder rate according to gender (male vs female responders, percentage) |
3-months
|
|
Cost-Effectiveness
Periodo de tiempo: 3 months
|
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. |
3 months
|
|
Socioeconomic Group/Area-related response
Periodo de tiempo: 3-months
|
Responder rate according to socioeconomic area (Index of Multiple Deprivation decile 1-10), percentage |
3-months
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Silla de estudio: Joerg Steier, PhD, Guy's & St Thomas' NHS Foundation Trust, London, UK
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- ZEUSi4i-1.0-03/12/25
- NIHR209411 (Otro número de subvención/financiamiento: National Institute for Health and Care Research (NIHR))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Pending ethics approval and medio-legal framework (GDPR)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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