- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02068703
Sleep Enhancing Tools: Pilot Study
Use of Sleep Enhancing Tools Impact on Self-Reported Sleep Survey
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- UMichigan
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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.
|
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.
|
Placebo komparator: Inert Control
Same 10 min time exposure and tool delivery to subjects in this arm WITHOUT demonstration.
|
Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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
Tidsramme: Baseline to day 3
|
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.
|
Baseline to day 3
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Effect of use of sleep tool devices on length of stay
Tidsramme: number hospital days between administration of tool and hospital discharge
|
Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced length of hospital stay
|
number hospital days between administration of tool and hospital discharge
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Effect of sleep enhancing tools on medication use
Tidsramme: baseline to day 3
|
Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced use of sleep or pain medication
|
baseline to day 3
|
Effect of sleep enhancing tools on participation in Occupational therapy
Tidsramme: baseline to day 3
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Peter Farrehi, MD, University of Michigan
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- HUM00075628
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