Clinical Trial

Relationship Between Sleep-Wake Quality and Nocturnal Medical Orders

Completed
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Summary
The goal of this randomized controlled clinical trial is to evaluate if the implementation of an adjusted nighttime medical order protocol can improve sleep quality and stabilize physiologic parameters in hospitalized adult patients admitted to general wards. 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-03.
Status change: Active, Not Recruiting → Completed 2026-06-10
Trial Details
NCT Number NCT07288775
Lead Sponsor Hospital Clinica Nova
Conditions Sleep Quality
Enrollment 51 participants
Start Date 2024-04-12
Primary Completion 2025-09-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-12