Phase II Study - Trial of a Phototherapy Light Device to Improve Sleep Health (PHOTONS)
2021年11月1日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
30
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
Arizona
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Tucson、Arizona、アメリカ、85719
- 募集
- Department of Psychiatry, University of Arizona
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コンタクト：
- Michael A Grandner, PhD
- 電話番号：520-626-6246
- メール：grandner@email.arizona.edu
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コンタクト：
- Chloe CA Wills
- 電話番号：520 626 1737
- メール：chloecawills@psychiatry.arizona.edu
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
30年～60年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Active
An active phototherapy device
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The active phototherapy device will emit light
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偽コンパレータ：Sham (Placebo)
An inactive device
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The active phototherapy device will emit light
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in subjective rating of the device across a 3-week intervention
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in mean sleep latency assessed using sleep diaries
時間枠：Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
|
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
時間枠：Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
|
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
時間枠：Change from baseline (pre) to post three weeks of wearing the phototherapy device (Day 21).
|
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
時間枠：Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
|
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).
|
Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
|
|
Change in sleep efficiency assessed using morning sleep diaries over the duration of the study
時間枠：Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
|
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).
|
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
時間枠：Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
|
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).
|
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
時間枠：Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
|
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).
|
Change from mean baseline period (first two weeks of wear) to post three weeks of wearing the phototherapy device.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年9月2日
一次修了 (予想される)
2022年1月30日
研究の完了 (予想される)
2022年1月30日
試験登録日
最初に提出
2021年11月1日
QC基準を満たした最初の提出物
2021年11月1日
最初の投稿 (実際)
2021年11月11日
学習記録の更新
投稿された最後の更新 (実際)
2021年11月11日
QC基準を満たした最後の更新が送信されました
2021年11月1日
最終確認日
2021年11月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2012256803
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いいえ
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いいえ
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