Relationship Between Sleep-Wake Quality and Nocturnal Medical Orders
NCT ID: NCT07288775
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
51 participants
INTERVENTIONAL
2024-04-12
2026-01-01
Brief Summary
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The main questions it aims to answer are:
Does reducing non-urgent nocturnal medical interruptions increase total sleep time and REM duration? Does improving sleep continuity enhance subjective sleep quality and physiologic stability (heart rate, blood pressure)? Researchers will compare the intervention group (patients under an adjusted nighttime order protocol) with the control group (standard hospital care) to determine whether reorganizing nighttime medical routines improves objective and perceived sleep outcomes.
Participants will:
Wear a Fitbit Sense® device to continuously monitor objective sleep parameters across three hospital nights.
Complete the Pittsburgh Sleep Quality Index (PSQI) at admission and discharge to assess subjective sleep quality.
Undergo standard nighttime vital sign evaluations according to their assigned study protocol.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention
Sleep enhancement intervention
Adjusted nocturnal medical orders
Control
Standard
Standard hospital care
Interventions
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Sleep enhancement intervention
Adjusted nocturnal medical orders
Standard
Standard hospital care
Eligibility Criteria
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Inclusion Criteria
* Aged 18-65 years
* Hospitalized in the general ward of Hospital Clínica Nova
* Minimum in-hospital stay ≥ 3 days
* Visual Analog Scale for pain \< 3
* Glasgow Coma Scale \> 13
Exclusion Criteria
* History of sleep disorders or obstructive sleep apnea
* Use of antidepressants, anxiolytics, hypnotics, or CNS stimulants
* Hemodynamic instability upon admission or during hospitalization
* Patients transferred from the ICU
18 Years
65 Years
ALL
Yes
Sponsors
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Hospital Clinica Nova
OTHER
Responsible Party
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Maria Elena Romero Ibarguengoitia
Principal Investigator
Locations
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Hospital Clinica Nova de Monterrey
San Nicolás de los Garza, Nuevo León, Mexico
Countries
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Other Identifiers
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Sleep
Identifier Type: -
Identifier Source: org_study_id