Sleep Enhancing Tools: Pilot Study
Use of Sleep Enhancing Tools Impact on Self-Reported Sleep Survey
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
A randomized, clinical pilot to trial the effect of sleep tools on patients' perception of sleep within the hospital setting.
We propose to conduct this pilot study to improve subjective symptoms of sleep deprivation in non-ICU hospitalized subjects by performing a brief intervention, easily performed at the point of care. Given the heterogeneity of hospitalized patients with varying ages, co-morbidities and other factors (such as pain and fatigue), we felt that an initial pilot study should focus on acceptability of three sleep aids (ear plugs, eye masks and white noise machine) among hospitalized non-ICU patients. Patients will be able to choose which aid they use and will be allowed to change aids during their hospital stay.
The primary outcomes of this study will be 1) improvement in perceived sleep quality as measured by PROMIS, a validated patient-reported outcome information system and 2) quality of care measures (length of stay, medication use and participation in therapy sessions).
PROMIS (Patient Reported Outcomes Measurement Information System) is an NIH sponsored health survey tool.
Information on characteristics (both patient and environment) including demographics, illness severity, number of medications, specific medications (such as sedatives and pain medications) will be collected to examine which predictors of improved perception of sleep quality correlate with use of sleep aids. This study is intended to focus on modifying the environment at the patient level rather than addressing the sources of environmental hospital noise.
Our study has the potential to impact this field with a preventative education based intervention, using simple tools in the non-ICU setting. It is important to understand this is not a study measuring sleep objectively but whether hospitalized patients perceive they sleep better if sleep aids are used.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- UMichigan
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Admitted to a private room in the hospital
- Speak and read english
- expected length of stay > 2 days
Exclusion Criteria:
- Hearing aids
- sleep apnea using positive airway pressure therapy
- medically or behaviorally unstable
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Intervention
Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools (face mask, ear plugs and white noise machine) to improve sleep.
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Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.
Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools to improve sleep.
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Comparateur placebo: Inert Control
Same 10 min time exposure and tool delivery to subjects in this arm WITHOUT demonstration.
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Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Aggregate change in sleep /pain / fatigue scores on Patient Reported Outcomes Measurement Information System (PROMIS) survey sampled in hospital from baseline to day 3 between study groups
Délai: Baseline to day 3
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Change from baseline in sleep / pain / fatigue scores on PROMIS survey in the hospital.
Each score ranges from 1-5, 1 equals not at all; 5 equals Very much.
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Baseline to day 3
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Effect of use of sleep tool devices on length of stay
Délai: number hospital days between administration of tool and hospital discharge
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Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced length of hospital stay
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number hospital days between administration of tool and hospital discharge
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Effect of sleep enhancing tools on medication use
Délai: baseline to day 3
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Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced use of sleep or pain medication
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baseline to day 3
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Effect of sleep enhancing tools on participation in Occupational therapy
Délai: baseline to day 3
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Whether the intervention of using sleep enhancing tools will translate into increased number of days participating in therapy during the study
|
baseline to day 3
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Peter Farrehi, MD, University of Michigan
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- HUM00075628
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