CompletedNot Applicable

Relationship Between Sleep-Wake Quality and Nocturnal Medical Orders

Mexico51 participantsStarted 2024-04-12

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female patients admitted within the past 24 hours * 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: * Visual, hearing, intellectual, or cognitive disability * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objetive changes in REM sleep

Timeframe: 3 days

Subjective sleep quality changes

Timeframe: 3 nights

Trial details

NCT IDNCT07288775

SponsorHospital Clinica Nova

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

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