Relationship Between Sleep-Wake Quality and Nocturnal Medical Orders

NCT07288775 | Active Not Recruiting DMC

• 1 other identifier: Sleep
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Quality

Keywords

sleep hygine; REM sleep; Non-REM sleep

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Differences in sleep-wake quality between male and female participants

  3 nights

• Association between sleep-wake quality and participant age

  3 nights

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

  3 nights

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

  3 nights

• Objective changes in NREM sleep

  3 nights

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Behavioral: Sleep enhancement intervention

Control

PLACEBO COMPARATOR

Behavioral: Standard

Interventions

Standard BEHAVIORAL

Standard hospital care

Control

Sleep enhancement intervention BEHAVIORAL

Adjusted nocturnal medical orders

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinica Nova: lead

Study Sites (1)

Hospital Clinica Nova de Monterrey

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

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 17, 2025
• Study Start: April 12, 2024
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

ME (1)