Phase II Study - Trial of a Phototherapy Light Device to Improve Sleep Health (PHOTONS)
1 novembre 2021 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Anticipato)
30
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Arizona
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Tucson, Arizona, Stati Uniti, 85719
- Reclutamento
- Department of Psychiatry, University of Arizona
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Contatto:
- Michael A Grandner, PhD
- Numero di telefono: 520-626-6246
- Email: grandner@email.arizona.edu
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Contatto:
- Chloe CA Wills
- Numero di telefono: 520 626 1737
- Email: chloecawills@psychiatry.arizona.edu
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 30 anni a 60 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Active
An active phototherapy device
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The active phototherapy device will emit light
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Comparatore fittizio: Sham (Placebo)
An inactive device
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The active phototherapy device will emit light
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in subjective rating of the device across a 3-week intervention
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in mean sleep latency assessed using sleep diaries
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
2 settembre 2021
Completamento primario (Anticipato)
30 gennaio 2022
Completamento dello studio (Anticipato)
30 gennaio 2022
Date di iscrizione allo studio
Primo inviato
1 novembre 2021
Primo inviato che soddisfa i criteri di controllo qualità
1 novembre 2021
Primo Inserito (Effettivo)
11 novembre 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 novembre 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 novembre 2021
Ultimo verificato
1 novembre 2021
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 2012256803
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .