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Sleep–Wake Quality after Nighttime Medical Adjustments

Controlled clinical trial on sleep–wake quality and nighttime medical order adjustments in hospitalized patients at Hospital Clínica Nova

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7dd6wcz
Enrollment
Unknown
Registered
2025-11-12
Start date
2024-04-12
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep REM

Interventions

This is a randomized controlled clinical trial with two arms, single-blind, including a total of 128 hospitalized participants aged 18 to 65 years at Hospital Clínica Nova, randomly assigned through a

Sponsors

servicios integrales nova de monterrey sociedad anonima de capital variable
Lead Sponsor
servicios integrales nova de monterrey sociedad anonima de capital variable
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients of both sexes admitted within the last 24 hours. Age between 18 and 65 years. Hospitalized in the inpatient unit of Hospital Clínica Nova. Expected hospital stay = 3 days. Visual Analog Scale (VAS) for pain < 3. Glasgow Coma Scale > 13

Exclusion criteria

Exclusion criteria: Visual, auditory, intellectual, or cognitive impairment. History of sleep disorders. History of obstructive sleep apnea syndrome. Use of antidepressants, anxiolytics, hypnotics, or central nervous system stimulants. Hemodynamic instability upon admission. Patients transferred from the intensive care unit

Design outcomes

Primary

MeasureTime frame
It is expected that the intervention group will show a lower score on the Pittsburgh Sleep Quality Index (PSQI) and a longer total Rapid Eye Movement (REM) sleep duration compared to the control group, after two nights of intervention relative to the baseline night.

Secondary

MeasureTime frame
Successful validation of the modified Pittsburgh Sleep Quality Index for inpatient use, demonstrating adequate internal consistency and concurrent validity;Improved sleep–wake quality will be observed in the intervention group, with significant differences across genders;A positive correlation between sleep–wake quality and age will be identified, showing greater improvement among younger adults in the intervention group;A relationship between BMI and sleep–wake quality will be established, with a more favorable impact in patients with normal BMI within the intervention group;Determinants influencing sleep–wake quality among hospitalized patients aged 18–65 years at HCN will be identified, highlighting modifiable environmental and clinical factors;A significant improvement in vital signs (heart rate, respiratory rate, body temperature, and oxygen saturation) will be documented in the intervention group compared to the control group

Countries

Mexico

Contacts

Public ContactSofia Parra Avila

Servicios Integrales Nova de Monterrey S.A. de C.V.

sofiparra2009@gmail.com+528182105008

Outcome results

None listed

Source: REBEC (via WHO ICTRP)