Relationship Between Sleep-Wake Quality and Nocturnal Medical Orders

Hospital Clinica Nova

Status: Active, not recruiting

Conditions: Sleep Quality

Treatments: Behavioral: Sleep enhancement intervention; Behavioral: Standard

Study type: Interventional

Funder types: Other

Identifiers

NCT07288775

Sleep

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Treatment:

Behavioral: Sleep enhancement intervention

Control

Placebo Comparator group

Treatment:

Behavioral: Standard