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Enhancement of Sleep With Wearables (WESA)

2 de marzo de 2021 actualizado por: Swiss Federal Institute of Technology

Enhancement of Sleep Slow Wave Activity Using Wearable Auditory Stimulation Devices and Its Consequences on Daytime Functioning: a Randomized, Counter-balanced Crossover Study

Sleep, specifically deep sleep, plays a central role in healthy brain function, cardio-vascular processes, mood and quality of life. Auditory stimulation during one night of sleep has previously been shown to improve deep sleep and along with memory formation in both young and older adults. Yet, it remains unclear whether long-term auditory stimulation considerably improves sleep quality over longer time periods and how it affects daytime functioning such as cognition, mood, quality of life and peripheral functions (e.g. cardio-vascular). Due to the importance of deep sleep for brain and body and the presence of many conditions that involve reduced deep sleep (e.g. ageing) assessing the beneficial impact of long-term sleep enhancement and its consequences is of central interest.This study will assess the effect of auditory stimulation over two weeks (interleaved with a two weeks washout period) in a cohort of healthy young and older adults using portable recording and stimulation devices.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

33

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Suiza
    • Zurich
      • Zürich, Zurich, Suiza, 8092
        • Swiss Federal Institute of Technology

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 84 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Informed Consent as documented by signature
  • For women: Hormonal contraception, if menstrual cycle is still present or has been present less than a year ago
  • Good general health status
  • Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study
  • Male and Female subjects 18-35 years of age or 60-84 years of age
  • German speaking

Exclusion Criteria:

  • Women who are pregnant or breast feeding,
  • Known or suspected non-compliance, drug or alcohol abuse,
  • Intake of sleep altering medication
  • Inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits
  • Participation in another study with investigational drug within the 30 days preceding and during the present study,
  • Presence or history of diagnosed psychiatric/neurologic disorder/lesion of the central nervous system (CNS),
  • Diagnosed internal disease,
  • Presence of sleep disorders,
  • Shift-work (work during the night) or situations that require several awakenings during the night (e.g. newborn)
  • Travelling more than 2 time zones in the last month before intervention starts or during intervention (study start will be shifted accordingly)
  • Hearing disability/ hearing aid
  • Skin disorders/problems in face region that will worsen with /not allow adhesive electrode application
  • Nicotine/Cannabis use
  • High caffeine consumption (> 5 servings/day; including coffee, energy drink)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Application of tones
During non-rapid eye movement (NREM) sleep short tones will be played
Dispositivo: Application of tones
During NREM sleep, tones (max. 60 dB) will be played using a portable, safe, in-home device. This device records biosignals (e.g. brain activity) and precisely times the tones during NREM sleep. It was developed and produced by the ETH Zurich and approved for use in this study by Swissmedic
Comparador falso: No application of tones
During NREM sleep no short tones will be played
Dispositivo: No application of tones
This is the sham-control intervention; The device will only record biosignals but will not play tones.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sleep quality
Periodo de tiempo: From baseline period to study completion, assessed up to 2 months
Objective information about sleep macro- and microstructure will be assessed including measures like sleep architecture, amount of slow wave activity (SWA), amount of spindles, awakenings during sleep, and sleep fragmentation. In addition, subjective sleep quality will be obtained by questionnaires every morning over the intervention period. These measures will show whether auditory stimulation enhanced overall sleep quality compared to sham.
From baseline period to study completion, assessed up to 2 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Daily functioning - Mood
Periodo de tiempo: From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks
Mood will be digitally assessed using a daily mood scale over the intervention period
From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks
Daily functioning - Quality of life
Periodo de tiempo: From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks
Quality of life will be assessed using a World Health Organization (WHO) quality of life assessment before and after each intervention period
From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks
Daily functioning - Vigilance
Periodo de tiempo: From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks
Vigilance will be assessed using a digital psychomotor vigilance task, assessed daily over the intervention period
From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks
Daily functioning - Cognition
Periodo de tiempo: From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks
Cognition will be assessed using a digital test battery before and after each intervention
From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks
Physiological parameters - Cardiovascular
Periodo de tiempo: From baseline period to study completion, assessed up to 2 months
R-R interval based assessments will be obtained using wearable monitors
From baseline period to study completion, assessed up to 2 months
Physiological parameters - Physical activity
Periodo de tiempo: Through study completion, approximately 2 months
Physical activity levels will be obtained using wearable monitors
Through study completion, approximately 2 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Device usability
Periodo de tiempo: From the first home visit until the end of the second intervention period, assessed within a time period up to 2 months
Questionnaires will be used to track specific information about the portable intervention device including information about its usability, discomfort and blinding to the condition
From the first home visit until the end of the second intervention period, assessed within a time period up to 2 months
Diary
Periodo de tiempo: Through study completion, approximately 2 months
Information about daily habits will be digitally assessed
Through study completion, approximately 2 months
Incidence of Intervention-related Adverse Events [Safety and Tolerability]
Periodo de tiempo: Through study completion, approximately 2 months
Any adverse or serious adverse events during the study period will be assessed
Through study completion, approximately 2 months
Chronotype
Periodo de tiempo: Before start of intervention period (single-time assessment during one initial 1-day visit)
Assessment of circadian type
Before start of intervention period (single-time assessment during one initial 1-day visit)
Handedness
Periodo de tiempo: Before start of intervention period (single-time assessment during one initial 1-day visit)
Assessment of handedness
Before start of intervention period (single-time assessment during one initial 1-day visit)
Menstrual cycle
Periodo de tiempo: Before start of intervention period (single-time assessment during one initial 1-day visit)
Assessment of menstrual cycle information in woman
Before start of intervention period (single-time assessment during one initial 1-day visit)
Height
Periodo de tiempo: Before start of intervention period (single-time assessment during one initial 1-day visit)
Assessment of height
Before start of intervention period (single-time assessment during one initial 1-day visit)
Hip-to-waist ratio
Periodo de tiempo: Before start of intervention period (single-time assessment during one initial 1-day visit)
Assessment of hip and waist circumference
Before start of intervention period (single-time assessment during one initial 1-day visit)
Blood pressure
Periodo de tiempo: Through study completion, approximately 2 months
Assessment of blood pressure
Through study completion, approximately 2 months
Weight
Periodo de tiempo: Before start of intervention period (single-time assessment during one initial 1-day visit)
Assessment of weight
Before start of intervention period (single-time assessment during one initial 1-day visit)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Swiss Federal Institute of Technology

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de mayo de 2018

Finalización primaria (Actual)

5 de marzo de 2019

Finalización del estudio (Actual)

30 de octubre de 2020

Fechas de registro del estudio

Enviado por primera vez

4 de diciembre de 2017

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2018

Publicado por primera vez (Actual)

5 de febrero de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de marzo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

2 de marzo de 2021

Última verificación

1 de marzo de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • WESA_2017-01436

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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