Relationship Between Sleep-Wake Quality and Nocturnal Medical Orders

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Quality
• Intervention / Treatment: Behavioral: Sleep enhancement intervention; Behavioral: Standard

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Nuevo León
    • San Nicolás de los Garza, Nuevo León, Mexico, 66450
      • Hospital Clinica Nova de Monterrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Behavioral: Standard; Standard hospital care
Active Comparator: Intervention	Behavioral: Sleep enhancement intervention; Adjusted nocturnal medical orders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objetive changes in REM sleep	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.	3 days
Subjective sleep quality changes	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.	3 nights

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in sleep-wake quality between male and female participants	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	3 nights
Association between sleep-wake quality and participant age	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 nights
Association between sleep-wake quality and body mass index (BMI).	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.	3 nights
Changes in vital signs (heart rate, respiratory rate, body temperature, and oxygen saturation) between the intervention and control groups	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.	3 nights
Objective changes in NREM sleep	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	3 nights

Collaborators and Investigators

• Sponsor: Hospital Clinica Nova

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Actual): September 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: REM sleep; Non-REM sleep; sleep hygine
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: Sleep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No