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Completed

NCT Number: NCT07288775

Relationship Between Sleep-Wake Quality and Nocturnal Medical Orders

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.

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Key information

Conditions

Sleep Quality Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinica Nova de Monterrey

San Nicolás de los Garza, Nuevo León, 66450, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep enhancement intervention

Behavioral

Adjusted nocturnal medical orders

Standard

Behavioral

Standard hospital care

Primary outcomes

  1. Objetive changes in REM sleep

    Time frame: 3 days

    Change in REM sleep duration (minutes), objectively measured using the Fitbit Sense, after two consecutive nights with reduced nocturnal interruptions compared with one baseline night without modification of medical instructions, and between groups with and without the intervention.

  2. Subjective sleep quality changes

    Time frame: 3 nights

    Sleep-wake quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI), a validated instrument that evaluates subjective sleep quality across seven components. PSQI global scores will be compared between the intervention and control groups to determine whether reducing nocturnal interruptions is associated with improved subjective sleep-wake quality.

Secondary outcomes

  1. Differences in sleep-wake quality between male and female participants

    Time frame: 3 nights

    Sleep-wake quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire that evaluates subjective sleep quality across seven components (sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, daytime dysfunction, and overall sleep quality). PSQI global scores will be compared between male and female participants to determine gender-related differences in sleep-wake quality

  2. Association between sleep-wake quality and participant age

    Time frame: 3 nights

    Sleep-wake quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). The association between PSQI global scores and participant age will be analyzed to determine whether increasing age correlates with changes in subjective sleep-wake quality.

  3. Association between sleep-wake quality and body mass index (BMI).

    Time frame: 3 nights

    Sleep-wake quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI). The association between PSQI global scores and body mass index (BMI) will be explored to evaluate whether differences in BMI are related to variations in subjective sleep-wake quality.

  4. Changes in vital signs (heart rate, respiratory rate, body temperature, and oxygen saturation) between the intervention and control groups

    Time frame: 3 nights

    Vital signs-including heart rate, respiratory rate, body temperature, and oxygen saturation-will be monitored using standard clinical measurement devices and/or Fitbit Sense sensor data (as applicable). Changes in these parameters will be compared between the intervention group and the control group to determine whether reducing nocturnal interruptions results in measurable physiologic differences.

  5. Objective changes in NREM sleep

    Time frame: 3 nights

    Change in NREM sleep duration (minutes), objectively measured using the Fitbit Sense, after two consecutive nights with reduced nocturnal interruptions compared with one baseline night without modification of medical instructions. And compared between groups with and without the intervention

Sponsors and collaborators

Lead sponsor

Hospital Clinica Nova

Other

Registry information

Official study title

Controlled Clinical Trial Between Sleep-Wake Quality and Adjustment of Nocturnal Medical Orders in Hospitalized Patients at Hospital Clinica Nova

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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