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- Essai clinique NCT04506151
Optimisation du sommeil pour améliorer le contrôle glycémique chez les adultes atteints de diabète de type 1 (SOPT)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60612
- University of Illinois Chicago
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
Critère d'intégration:
- adultes âgés de 18 à 65 ans
- diagnostic clinique de diabète de type 1 depuis au moins un an
- a signalé une variabilité habituelle du sommeil (1 heure/semaine ou plus) ou une durée de sommeil inférieure à 6,5 heures/nuit pendant les jours de travail ou de semaine (confirmée par une montre de sommeil actigraphique)
- un désir d'améliorer le sommeil
- posséder un smartphone
Critère d'exclusion:
- symptômes d'insomnie
- à haut risque d'apnée obstructive du sommeil
- épisode d'hypoglycémie sévère au cours des 6 derniers mois (par ex. perte de conscience)
- A1C supérieur à 10 %
- travail posté en rotation ou travail de nuit
- utilisation de somnifères/aides somnifères
- insuffisance rénale (taux de filtration glomérulaire estimé < 45 ml/min)
- morbidités médicales actuelles importantes (telles que insuffisance cardiaque, cirrhose, maladie pulmonaire obstructive chronique nécessitant de l'oxygène, traitement actif contre le cancer, dépression, antécédents d'accident vasculaire cérébral avec déficits neurologiques
- allaitement, enceinte ou planification de grossesse
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 |
|---|---|
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Expérimental: Opt sommeil
Intervention de 12 semaines qui comprend l'autosurveillance, l'établissement d'objectifs et l'amélioration de la motivation.
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Intervention comportementale de 12 semaines
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Comparateur actif: Mode de vie sain
Intervention de 12 semaines qui comprend un contact téléphonique hebdomadaire, un contenu didactique égal dans le temps et l'attention au groupe d'intervention.
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Mode de vie sain
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Sleep Variability Week 6
Délai: Week 6
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Standard deviation total sleep time for one week
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Week 6
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Sleep Variability Week 12
Délai: Week 12
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Standard deviation total sleep time for one week
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Week 12
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Sleep Variability Week 24
Délai: Week 24
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Standard deviation total sleep time for one week
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Week 24
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Sleep Duration Week 6
Délai: Weeks 6
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total sleep time minutes
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Weeks 6
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Sleep Duration Week 12
Délai: Week 12
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total sleep time in minutes
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Week 12
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Sleep Duration Week 24
Délai: Week 24
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total sleep time in minutes
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Week 24
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HbA1C Week 6
Délai: Week 6
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Hemoglobin A1C week 6, %
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Week 6
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HbA1C Week 12
Délai: Week 12
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HbA1c blood test
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Week 12
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HbA1C Week 24
Délai: Week 24
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HbA1c blood test
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Week 24
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diabetes Distress Week 6
Délai: Week 6
|
Type 1 Diabetes Distress Scale measures diabetes distress.
Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
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Week 6
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Diabetes Distress Week 12
Délai: Week 12
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Type 1 Diabetes Distress Scale measures diabetes distress.
Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
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Week 12
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Diabetes Distress Week 24
Délai: Week 24
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Type 1 Diabetes Distress Scale measures diabetes distress.
Item mean scores calculated (sum of scores/number of items) ranges from 1-6 Higher scores indicated greater distress Unit of measure = units on a scale
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Week 24
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Self-management Behavior Week 6
Délai: Week 6
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Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items * 10).
Ranges from 0-10.
Higher numbers indicate better self-management behavior Unit of measure = units on a scale
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Week 6
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Self Management Behavior Week 12
Délai: Week 12
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Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items * 10).
Scores ranges from 0-10.
Higher numbers indicate better self-management behavior Unit of measure = units on a scale
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Week 12
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Self Management Behavior Week 24
Délai: Week 24
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Diabetes Self Management Questionnaire-R (DSMQ-R) measures diabetes self-management Item mean scores calculated (sum of scores/maximum possible sum of items * 10).
Ranges from 0-10.
Higher numbers indicate better self-management behavior Unit of measure = units on a scale
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Week 24
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Quality of Life Week 6
Délai: Week 6
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Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range * 100. Scores range from 0-100. Scores are reverse coded so that higher numbers indicate better quality of life. Unit of measure = units on a scale |
Week 6
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Quality of Life Week 12
Délai: Week 12
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Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range * 100. Scores range from 0-100. Scores are reverse coded so that higher numbers indicate better quality of life. Unit of measure = units on a scale. |
Week 12
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Quality of Life Week 24
Délai: Week 24
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Diabetes Quality of Life scale measures quality of life Total quality of life score calculated as follows: (Raw total score - lowest possible score)/raw score range * 100. Scores range from 0-100. Scores are reverse coded so that higher numbers indicate better quality of life. Unit of measure = units on a scale. |
Week 24
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Fatigue Week 6
Délai: Week 6
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Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue. The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue. |
Week 6
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Fatigue Week 12
Délai: Week 12
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Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue. The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue. |
Week 12
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Fatigue Week 24
Délai: Week 24
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Patient Reported Outcomes Measure (PROMIS) fatigue scale score measures fatigue. The total score was converted to T-scores (with T-scores, 50 indicates the population mean with a standard deviation of 10). Mean T-scores were calculated. Higher scores reflect greater fatigue. |
Week 24
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Mood Week 6
Délai: Week 6
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Center for Epidemiological Studies-Depression (CES-D) measures depressive mood.
Total summed score ranges from 0-60.
Higher scores indicate greater depressive mood.
Unit of measure = units on a scale.
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Week 6
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Mood Week 12
Délai: Week 12
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Center for Epidemiological Studies-Depression (CES-D) measures depressive mood.
Total summed score ranges from 0-60.
Higher scores indicate greater depressive mood.
Unit of measure = units on a scale.
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Week 12
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Mood Week 24
Délai: Week 24
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Center for Epidemiological Studies-Depression (CES-D) measures depressive mood.
Total summed score ranges from 0-60.
Higher scores indicate greater depressive mood.
Unit of measure = units on a scale.
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Week 24
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Subjective Sleep Quality Week 6
Délai: Week 6
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Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality.
Total summed score ranges 0-21.
Higher score reflects poorer sleep quality.
Unit of measure = units on a scale.
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Week 6
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Subjective Sleep Quality Week 12
Délai: Week 12
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Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality.
Total summed score ranges 0-21.
Higher score reflects poorer sleep quality.
Unit of measure = units on a scale.
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Week 12
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Subjective Sleep Quality Week 24
Délai: Week 24
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Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality.
Total summed score ranges 0-21.
Higher score reflects poorer sleep quality.
Unit of measure = units on a scale.
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Week 24
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Glycemic Variability Week 6
Délai: Week 6
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Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
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Week 6
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Glycemic Variability Week 12
Délai: Week 12
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Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
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Week 12
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Glycemic Variability Week 24
Délai: Week 24
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Coefficient of variation (CV%), continuous glucose monitoring (CGM)-derived glucose standard deviation (SD) divided by the mean and multiplied by 100.
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Week 24
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Glucose Time-in-range Week 6
Délai: Week 6
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Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
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Week 6
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Glucose Time-in-range Week 12
Délai: Week 12
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Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
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Week 12
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Glucose Time-in-range Week 24
Délai: Week 24
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Percent of time continuous glucose monitoring (CGM)-derived glucose is between 70-180 mg/dL.
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Week 24
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tests of the Sleep Intervention Effect on A1C That is Due to the Change in Sleep Duration
Délai: week 12
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Mediation tests of the sleep intervention effect on A1C that is due to the change in sleep duration.
It is the product of parameter estimates testing the effect of the intervention on sleep duration and the mediating effect of the change in sleep duration on A1C.
Markov chain Monte Carlo (MCMC) models were used.
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week 12
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Mediation Tests of the Sleep Intervention Effect on A1C That is Due to the Change in Sleep Variability.
Délai: Week 12
|
Results are not reported by treatment arm.
This analysis tests the sleep intervention effect on A1C that is mediated by the change in sleep variability.
The values reported are the product of parameter estimates testing the effect of the intervention on sleep variability and the effect of the change in sleep variability on A1C.
Markov chain Monte Carlo (MCMC) models were used.
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Week 12
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pamela Martyn-Nemeth, PhD, University of Illinois at Chicago
Publications et liens utiles
Publications générales
- Martyn-Nemeth P, Duffecy J, Quinn L, Reutrakul S, Steffen AD, Burke L, Clark Withington MH, Irsheed GA, Perez R, Park M, Saleh A, Mihailescu D, Baron KG. Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. Trials. 2022 Aug 19;23(1):686. doi: 10.1186/s13063-022-06565-6.
- Hong SJ, Pratuangtham S, Martyn-Nemeth P, Steffen AD, Park CG, Reutrakul S. Blue Light Exposure During Sleep in Type 1 Diabetes: Impacts on Glycemic Control and Psychosocial Health. J Sleep Res. 2026 Jun 5:e70380. doi: 10.1111/jsr.70380. Online ahead of print.
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
- 2020-0374
- 1R01DK121726 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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
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