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Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep

10 de septiembre de 2021 actualizado por: Steven W. Lockley, Brigham and Women's Hospital

Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep.

The timing and quality of sleep is governed by environmental and physiologic factors. Environmental factors, especially ambient lighting can impact the circadian system and alter the timing and structure of sleep. Light exposure can also acutely alter neural activation state and impair sleep. These effects all demonstrate marked sensitivity to short-wavelength blue light with maximal sensitivity in the 460-480 nm range. The alerting effects of blue light in the evening persist for at least 3-4 hours after the lights are turned off, and can disturb subsequent sleep. Avoiding these deleterious effects of light exposure prior to sleep on subsequent sleep would be beneficial to sleep quality and potentially health.

The investigators will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light. The investigators will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL). In a within-subject design, the investigators will test the hypotheses that exposure to a blue-depleted LED as compared to a CFL exposure at (1) 90 lux or (2) 50 lux will cause significantly:

  1. Less melatonin suppression between melatonin onset and bedtime;
  2. Less subjective and objective alerting responses before bedtime;
  3. Less disruption of nocturnal sleep structure and quality.

Descripción general del estudio

Estado

Terminado

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

    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Brigham and Women's Hospital

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 30 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

(i) Aged between 18-30 years to reduce the confounding effects of lens aging on the transmission of light to the retina;

(ii) Non-smoking for at least 6 months;

(iii) Healthy (no medical, psychiatric or sleep disorders);

(iv) No clinically significant deviations from normal in medical history, vital signs, physical examination, blood chemistry and hematology, urine chemistry and ECG;

(v) Women of childbearing potential must agree to use an acceptable method of birth control, and must have a negative urine pregnancy test;

(vi) Body mass index of > 18 or < 30 kg/m2;

(vii) No drugs or medication likely to affect sleep or alertness, as determined by the investigators;

(viii) Habitual caffeine consumption < 300mg per day on average;

(ix) Habitual alcohol consumption < 10 alcoholic units per week on average.

Exclusion Criteria:

(i) History of alcohol or substance abuse;

(ii) Positive result on drugs of abuse screening;

(iii) Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, or any significant sleep complaint;

(iv) Psychiatric disorder;

(v) Recent acute or chronic medical disorder, including but not limited to hepatic impairment and severe chronic obstructive pulmonary disease;

(vi) Visual disorder, including but not limited to color blindness, or family history of glaucoma;

(vii) History of intolerance or hypersensitivity to melatonin or melatonin agonists;

(viii) Pregnancy or lactation;

(ix) Shift work;

(x) Transmeridian travel (2 or more time zones) in past 2 months;

(xi) Any other reason as determined by the Principal Investigator.

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 factorial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Compact Fluorescent Light 90 lux
90 lux exposure of a commercially available Compact Fluorescent Light (CFL).
We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Experimental: Blue-depleted LED light 90 lux
90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Comparador activo: Compact Fluorescent Light 50 lux
50 lux exposure of a commercially available Compact Fluorescent Light (CFL).
We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Experimental: Blue-depleted LED light 50 lux
50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Melatonin Suppression
Periodo de tiempo: 6-h constant posture interval of the light exposure
Melatonin suppression is measured as the percentage of melatonin AUC relative to the AUC measured in dim light on the previous day. AUC was calculated during the 6 h of light exposure and the corresponding 6-h interval 24 hours earlier. Higher values indicate more light-induced melatonin suppression.
6-h constant posture interval of the light exposure

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sleep Structure
Periodo de tiempo: 8-h time in bed immediately following CFL/LED light exposure.
Sleep efficiency assessed by polysomnography. Sleep efficiency refers to the percentage of time a person sleeps, in relation to the amount of time a person spends in bed trying to sleep. The percentage is calculated by dividing the Total Sleep Time by the Total Time in Bed.
8-h time in bed immediately following CFL/LED light exposure.
Sleep Quality
Periodo de tiempo: First morning after 8-h time in bed immediately following CFL/LED light exposure.
Self-reported sleep quality was assessed using a post sleep questionnaire. Score on subjective scale range 1-7, higher scores indicate higher sleep quality.
First morning after 8-h time in bed immediately following CFL/LED light exposure.
Subjective Alerting Response
Periodo de tiempo: 6-h constant posture interval of the light exposure.
Self-reported sleepiness measured during the light exposure using the Karolinska Sleepiness Scale (KSS). Range of scores 1-9, higher score indicate higher subjective sleepiness. Measures were taken hourly throughout the 6-hour constant posture interval of the light exposure and then averaged to calculate a single value per participant.
6-h constant posture interval of the light exposure.
Objective Alerting Response
Periodo de tiempo: 6-h constant posture interval of the light exposure
Mean reaction time assessed using the 10-minute psychomotor vigilance test. Higher numbers indicate slower reaction times indicating less alertness. Measures were taken hourly throughout the 6-hour constant posture interval of the light exposure and then averaged to calculate a single value per participant.
6-h constant posture interval of the light exposure

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Steven W Lockley, Ph.D., Brigham and Women's Hospital; Harvard Medical School

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

1 de agosto de 2012

Finalización primaria (Actual)

1 de marzo de 2014

Finalización del estudio (Actual)

1 de marzo de 2014

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2012

Primero enviado que cumplió con los criterios de control de calidad

25 de abril de 2012

Publicado por primera vez (Estimar)

26 de abril de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de septiembre de 2021

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

10 de septiembre de 2021

Última verificación

1 de septiembre de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2011-P-002834

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

producto fabricado y exportado desde los 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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