Sleep Quality
Conditions
Keywords
sleep hygine, REM sleep, Non-REM sleep
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.
Interventions
BEHAVIORALSleep enhancement intervention
Adjusted nocturnal medical orders
BEHAVIORALStandard
Standard hospital care
Sponsors
Hospital Clinica Nova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objetive changes in REM sleep | 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. |
| Subjective sleep quality changes | 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
| Measure | Time frame | Description |
|---|---|---|
| Association between sleep-wake quality and body mass index (BMI). | 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. |
| Differences in sleep-wake quality between male and female participants | 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 |
| Objective changes in NREM sleep | 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 |
| Changes in vital signs (heart rate, respiratory rate, body temperature, and oxygen saturation) between the intervention and control groups | 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. |
| Association between sleep-wake quality and participant age | 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. |
Countries
Mexico
Outcome results
None listed