Phase II Study - Trial of a Phototherapy Light Device to Improve Sleep Health (PHOTONS)
1 de novembro de 2021 atualizado por: MICHAEL A GRANDNER, University of Arizona
There are few devices currently on the market claiming to improve sleep.
This study will investigate the efficacy of phototherapy on improving sleep, in the form of a wearable neck device used at night.
Visão geral do estudo
Descrição detalhada
This study will investigate the efficacy of phototherapy on improving sleep, in the form of a wearable neck device used at night.
Phototherapy has been shown to improve chronic pain, cerebral blood flow, neurological function, and capillary growth in skeletal muscle.
A device worn at night may improve sleep onset, total sleep time, or modify sleep architecture.
Improved cardiovascular function may facilitate a decrease in core body temperature needed for sleep onset.
Relaxation from direct heat may help to decrease cortisol levels, thus reducing the number of night-time arousals.
It may also decrease circulating levels of norepinephrine (NE), one of the main neurotransmitters involved in arousal.
The aim of this study is to evaluate if the device worn leads to greater next-day wellbeing and cognitive function as a result of increased slow-wave activity.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
30
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Arizona
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Tucson, Arizona, Estados Unidos, 85719
- Recrutamento
- Department of Psychiatry, University of Arizona
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Contato:
- Michael A Grandner, PhD
- Número de telefone: 520-626-6246
- E-mail: grandner@email.arizona.edu
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Contato:
- Chloe CA Wills
- Número de telefone: 520 626 1737
- E-mail: chloecawills@psychiatry.arizona.edu
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
30 anos a 60 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Between the ages of 18 and 60 years old
- Able to read and write fluently in English
- Access to a mobile device for video calls, online questionnaires, syncing devices, and communication with study staff
- Access to a residential mailing address for shipping study materials
- Exhibit a score of >8 on the Insomnia Severity Index
- Self-report that they have a problem with their sleep that they wish to improve
Exclusion Criteria:
- Have a moderate to severe current sleep disorder
- Have a current psychiatric disorder
- Are taking medication that would interfere with sleep, including beta blockers, antidepressants, antianxiety medications, hypnotics, or stimulants
- Have a medical condition that would interfere with their ability to complete all study procedures or would render measurements invalid (e.g., some autoimmune conditions, cardiac conditions, endocrine conditions, or chronic pain conditions)
- Exhibit a regular sleep schedule, where bed and wake times are kept within a 2-hour window 7 days per week
- Exhibit a regular sleep schedule during the night, beginning no earlier than 9pm and ending no later than 10am
- Have not engaged in shift work for the past month, and will refrain from shift work during the study
- Are unable to restrict alcohol consumption to no more than 2 drinks within 4 hours of sleep
- Are unable to restrict caffeine use to no coffee or caffeinated beverages after 12pm during the study
- Regularly smoke or use other tobacco products
- Regularly use cannabis-derived medicinal products
- Are pregnant
- Are a full-time caregiver to an individual that requires attending during the evening and night
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Active
An active phototherapy device
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The active phototherapy device will emit light
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Comparador Falso: Sham (Placebo)
An inactive device
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The active phototherapy device will emit light
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in subjective rating of the device across a 3-week intervention
Prazo: Change in subjective rating of the device from baseline (pre; Day 0) to after 21 days of wearing it (post)
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There will be a subjective rating of the phototherapy device using a series of questions assessing device's effect on sleep and next-day function at the end of the trial.
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Change in subjective rating of the device from baseline (pre; Day 0) to after 21 days of wearing it (post)
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Change in Insomnia Severity Index (ISI) scores across a 3-week intervention
Prazo: Change from baseline over the course of the study (after 21 days of wearing the device)
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The ISI is a 7-item insomnia screening tool that is the gold standard for quantifying severity of clinical insomnia symptoms.
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Change from baseline over the course of the study (after 21 days of wearing the device)
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Change in objective sleep efficiency across a 3-week intervention
Prazo: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Objective sleep efficiency will be measured with a wearable device (Oura ring) that is worn for the duration of the study and captures sleep and wake data using actigraphy.
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Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in mean sleep latency assessed using sleep diaries
Prazo: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Sleep latency, or time taken to fall asleep, will be assessed using morning sleep diaries completed by the participant upon awakening.
The mean sleep latency during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
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Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Change in Karolinska Sleepiness Scale (KSS) score
Prazo: Change from before intervention (pre) to post three weeks of wearing the phototherapy device (Day 21)..
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The Karolinska Sleepiness Scale (KSS) measures situational sleepiness on a 9-point scale
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Change from before intervention (pre) to post three weeks of wearing the phototherapy device (Day 21)..
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Circadian Energy Scale (CIRENS) score
Prazo: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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CIRENS is a very short and simple chronotype measurement tool based on energy.
The CIRENS consists of two introspective questions about the usual energy level (very low, low, moderate, high, or very high, scored 1 to 5) in the morning and in the evening.
The difference between energy level scores (-4 to 4) felt by respondents in the evening and morning defines the chronotype score and classification.
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Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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Positive and Negative Affect Scales (PANAS) Positive Affect
Prazo: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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The Positive and Negative Affect Scales are brief screening measures that assess both positive and negative emotional experiences.
This scale will allow for separate assessment of impact on positive mood.
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Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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Positive and Negative Affect Scales (PANAS) Negative Affect
Prazo: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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The Positive and Negative Affect Scales are brief screening measures that assess both positive and negative emotional experiences.
This scale will allow for separate assessment of impact on negative mood.
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Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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Change in Fatigue Severity Scale (FSS) across a three-week intervention
Prazo: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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Fatigue Severity Scale (FSS) is a well-validated 9-item clinical measure that assesses overall levels of mental and physical fatigue, with answers ranging from 1- "Strongly Disagree" to 7-"Strongly Agree".
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Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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Change in Profile of Mood States (POMS) across a three week intervention
Prazo: Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states.
The POMS measures six different dimensions of mood swings over a period of time.
These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment.
A total score will be evaluated in addition to the individual items.
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Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
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Change in Wake After Sleep Onset (WASO) assessed using morning sleep diaries over the duration of the study
Prazo: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Wake after sleep onset (WASO), or the number of nocturnal awakenings, will be assessed using morning sleep diaries completed by the participant upon awakening.
The mean WASO during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
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Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Change in sleep efficiency assessed using morning sleep diaries over the duration of the study
Prazo: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Sleep efficiency, or the amount of time spent asleep during a sleep opportunity, will be assessed using morning sleep diaries completed by the participant upon awakening.
The mean sleep efficiency during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
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Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Change in total sleep time assessed using morning sleep diaries over the duration of the study
Prazo: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Total sleep time will be assessed using morning sleep diaries completed by the participant upon awakening.
The mean total sleep time during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
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Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Change in morning refreshed feeling assessed using morning sleep diaries over the duration of the study
Prazo: Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Morning refreshed feeling will be assessed using morning sleep diaries completed by the participant upon awakening.
The mean refreshed feeling during the baseline period (pre) will be compared to after three weeks of wearing the phototherapy device (post).
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Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
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Colaboradores e Investigadores
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Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de setembro de 2021
Conclusão Primária (Antecipado)
30 de janeiro de 2022
Conclusão do estudo (Antecipado)
30 de janeiro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
1 de novembro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de novembro de 2021
Primeira postagem (Real)
11 de novembro de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de novembro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de novembro de 2021
Última verificação
1 de novembro de 2021
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 2012256803
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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