- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07659171
Light Therapy for University Students
Effects of Light Therapy on Well-being of University Students: A Pilot Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Reykjavik, Islande, 102
- Department of Psychology, Reykjavík University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Being a psychology student at Reykjavik University, Iceland
- Able to understand, read and write Icelandic
- At screening assessment prior to the intervention, demonstrating a score of three or above on any of the six items of the BIS scale, thereby including students who showed even mild symptoms of sleep problems
Exclusion Criteria:
- Not being a psychology student at Reykjavik University, Iceland
- Not able to understand, read and write Icelandic
- Demonstrating a score below three on all of the six items of the BIS scale
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Blue Light Therapy
Exposure of experimental circadian-effective blue light (BL) by glasses for 30 minutes each morning during the 3-week intervention
|
The circadian-effective light glasses used by the experimental group (BL) emitted narrowband (peak lambda = 470 nm) blue light with an irradiance of 250 μW/cm2 (120 lux). The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similar to a pair of regular glasses. For safety purposes, the light glasses do not contain UV or infra-red light. Brand: AYO glasses. |
|
Comparateur actif: Dim Light Therapy
Exposure of experimental comparison circadian-ineffective dim light (DL) by glasses for 30 minutes each morning during the 3-week intervention
|
The circadian-ineffective sham glasses (DL) emitted blue light with an irradiance of 2.5 μW/cm2 (1.16 lux). The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similar to a pair of regular glasses. For safety purposes, the light glasses do not contain UV or infra-red light. Brand: AYO glasses. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The Bergen Insomnia Scale (BIS)
Délai: BIS was used to screen for sleep-related problems, prior to the intervention, at baseline (day 1), at the middle of intervention (FU1, day 11) and at the of intervention (FU2, day 21).
|
The Bergen Insomnia Scale (BIS) is a short scale on sleep habits consisting of six items pertaining to sleep onset, maintenance, early morning wakening, restorative sleep, daytime functioning, and sleep satisfaction.
Responses indicate how often sleep problems, according to the six items, are experienced during the last month on an 8-point scale (0-7 days per week) with a range between 0 and 42, where a higher score suggests more sleep problems.
|
BIS was used to screen for sleep-related problems, prior to the intervention, at baseline (day 1), at the middle of intervention (FU1, day 11) and at the of intervention (FU2, day 21).
|
|
The Pittsburgh Sleep Quality Index (PSQI)
Délai: PSQI was administered at baseline (day 1), FU1 (day 11), and FU2 (day 21).
|
The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated items about sleep habits during the last month.
The questions are categorised into seven components, rated from 0 to 3, evaluating sleep duration, quality, and latency as well as habitual sleep efficiency, sleep disturbances, usage of sleep medication, and daytime dysfunction.
A global PSQI score, ranging from 0 to 21, is calculated by summarising the seven components' scores, where a higher global score indicates worse sleep quality and a score above five suggests poor sleep quality.
|
PSQI was administered at baseline (day 1), FU1 (day 11), and FU2 (day 21).
|
|
Objective sleep measure by actigraphy: Total time in bed
Délai: Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
Wrist-worn actigraphy devices (model GT3X+ ActiSleep) were used to objectively measure sleep.
Sleep parameters were calculated using the Cole-Kripke sleep algorithm in the ActiLife 6 data analysis software.
Parameter measured: Total time in bed, measured as minutes.
|
Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
|
Objective sleep measure by actigraphy: Total sleep time
Délai: Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
Wrist-worn actigraphy devices (model GT3X+ ActiSleep) were used to objectively measure sleep.
Sleep parameters were calculated using the Cole-Kripke sleep algorithm in the ActiLife 6 data analysis software.
Parameter measured: Total sleep time, measured as minutes.
|
Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
|
Objective sleep measure by actigraphy: Sleep latency
Délai: Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
Wrist-worn actigraphy devices (model GT3X+ ActiSleep) were used to objectively measure sleep.
Sleep parameters were calculated using the Cole-Kripke sleep algorithm in the ActiLife 6 data analysis software.
Parameter measured: Sleep latency, measured as minutes.
|
Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
|
Objective sleep measure by actigraphy: Wake after sleep onset
Délai: Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
Wrist-worn actigraphy devices (model GT3X+ ActiSleep) were used to objectively measure sleep.
Sleep parameters were calculated using the Cole-Kripke sleep algorithm in the ActiLife 6 data analysis software.
Parameter measured: Wake after sleep onset, measured as minutes.
|
Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
|
Objective sleep measure by actigraphy: Number of awakenings
Délai: Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
Wrist-worn actigraphy devices (model GT3X+ ActiSleep) were used to objectively measure sleep.
Sleep parameters were calculated using the Cole-Kripke sleep algorithm in the ActiLife 6 data analysis software.
Parameter measured: Number of awakenings, measured as number of awakenings per sleep period.
|
Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
|
Objective sleep measure by actigraphy: Sleep fragmentation index
Délai: Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
Wrist-worn actigraphy devices (model GT3X+ ActiSleep) were used to objectively measure sleep.
Sleep parameters were calculated using the Cole-Kripke sleep algorithm in the ActiLife 6 data analysis software.
Parameter measured: Sleep fragmentation index, measured as percentage.
|
Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
|
Objective sleep measure by actigraphy: Sleep movement index
Délai: Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
Wrist-worn actigraphy devices (model GT3X+ ActiSleep) were used to objectively measure sleep.
Sleep parameters were calculated using the Cole-Kripke sleep algorithm in the ActiLife 6 data analysis software.
Parameter measured: Sleep movement index, measured as events per hour.
|
Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
|
Objective sleep measure by actigraphy: Sleep efficiency
Délai: Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
Wrist-worn actigraphy devices (model GT3X+ ActiSleep) were used to objectively measure sleep.
Sleep parameters were calculated using the Cole-Kripke sleep algorithm in the ActiLife 6 data analysis software.
Parameter measured: Sleep efficiency, measured as percentage.
|
Participants were asked to wear the devices on their non-dominant arm for four consecutive days, both at baseline (day 1-4) and at FU2 (day 18-21).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The Center for Epidemiological Studies Depression Scale (CES-D)
Délai: CES-D was administered at baseline (day 1), FU1 (day 11) and FU2 (day 21).
|
The Center for Epidemiological Studies Depression Scale (CES-D) is a 20 item self-report instrument, designed to measure common symptoms of depression that have occurred over the past week such as poor appetite, hopelessness, pessimism, and fatigue.
Response options range from 0 to 3 for each item.
Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
|
CES-D was administered at baseline (day 1), FU1 (day 11) and FU2 (day 21).
|
|
General Anxiety Disorder (GAD-7)
Délai: GAD-7 was administered at baseline (day 1), FU1 (day 11) and FU2 (day 21).
|
General Anxiety Disorder (GAD-7) is a shorter version of the original GAD-13 item scale designed to measure anxiety.
Each of the seven questions is rated on a 4-point Likert scale based on symptom frequency.
The total score is calculated by summing the scores for all seven items, thus scores range from 0 to 21, with higer score meaning more anxiety.
Cut-points are as follows: 0-4: Minimal anxiety, 5-9: Mild anxiety, 10-14: Moderate anxiety, and 15-21: Severe anxiety.
A score of 10 or greater is often used as a clinical cut-off point.
|
GAD-7 was administered at baseline (day 1), FU1 (day 11) and FU2 (day 21).
|
|
The reduced Horne & Östberg Morningness-Eveningness Questionnaire (rMEQ)
Délai: rMEQ was administered at baseline (day 1).
|
The reduced Horne & Östberg Morningness-Eveningness Questionnaire (rMEQ) is a self-report questionnaire is one of the most widely used questionnaire to measure chronotype.
The rMEQ consists of 5 questions that assess an individual's preference for morning or evening activities.
Based on results from the scoring, individuals can be categorized as: Morning Types: Prefer morning activities; Evening Types: Prefer evening activities or Intermediate Types: Have no strong preference.
|
rMEQ was administered at baseline (day 1).
|
|
The Epworth Sleepiness Scale (ESS)
Délai: ESS was administered at baseline (day 1), FU1 (day 11) and FU2 (day 21).
|
The Epworth Sleepiness Scale (ESS) is widely used in sleep research and clinical settings and consists of 8 questions (each with 4 answering possibilities) about sleepiness.
measure a person's likelihood of dozing off during various daily activities.
ESS provides a score ranging from 0 to 24, with higher scores indicating excessive daytime sleepiness.
In general ESS scores can be interpreted as follows: 0-5 Lower Normal Daytime Sleepiness; 6-10 Higher Normal Daytime Sleepiness; 11-12 Mild Excessive Daytime Sleepiness; 13-15 Moderate Excessive Daytime Sleepiness; and 16-24 Severe Excessive Daytime Sleepiness.
|
ESS was administered at baseline (day 1), FU1 (day 11) and FU2 (day 21).
|
|
Objective measures of cognitive performance: Operation Span (Ospan)
Délai: Ospan was administered at baseline (day 1) and FU2 (day 21).
|
Three neuropsychological tests were used to measure cognitive performance: Operation Span (Ospan) is a cognitive task designed to measure working memory capacity by requiring participants to remember sequences of letters while simultaneously solving simple math problems.
This dual-task approach assesses how well individuals can manage their memory resources under distraction.
|
Ospan was administered at baseline (day 1) and FU2 (day 21).
|
|
Objective measures of cognitive performance: Digit span forward
Délai: Digit span forward was administered at baseline (day 1) and FU2 (day 21).
|
Three neuropsychological tests were used to measure cognitive performance: Digit span forward is a cognitive task where a person listens to a sequence of numbers and then repeats them back in the same order.
This task primarily measures short-term auditory memory and is commonly used in psychological assessments to evaluate working memory capacity.
|
Digit span forward was administered at baseline (day 1) and FU2 (day 21).
|
|
Objective measures of cognitive performance: Digit span backward
Délai: Digit span backward was administered at baseline (day 1) and FU2 (day 21).
|
Three neuropsychological tests were used to measure cognitive performance: Digit span backward is a cognitive task that measures short-term memory by requiring participants to recall a sequence of numbers in reverse order.
This task is more challenging than recalling the numbers in the original order, as it involves both storage and manipulation of the information.
|
Digit span backward was administered at baseline (day 1) and FU2 (day 21).
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Birna Baldursdottir, PhD, Reykjavík University, Iceland
Publications et liens utiles
Publications générales
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- Pallesen S, Bjorvatn B, Nordhus IH, Sivertsen B, Hjornevik M, Morin CM. A new scale for measuring insomnia: the Bergen Insomnia Scale. Percept Mot Skills. 2008 Dec;107(3):691-706. doi: 10.2466/pms.107.3.691-706.
- Radloff, L. S. (1977). The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement, 1(3), 385-401. doi:10.1177/014662167700100306
- Danielsson K, Sakarya A, Jansson-Frojmark M. The reduced Morningness-Eveningness Questionnaire: Psychometric properties and related factors in a young Swedish population. Chronobiol Int. 2019 Apr;36(4):530-540. doi: 10.1080/07420528.2018.1564322. Epub 2019 Jan 7.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- VSN-19054
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .