Determinants of Sleep Quality in Spanish Population (SSQD Study)

NCT ID: NCT05324267

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-08-31

Brief Summary

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Introduction: Sleep disorders are a growing concern for public health, being related, among others, to an increased risk of cardiovascular diseases or poorer cognitive functioning. In addition, these might have a possible impact on aspects related to personal motivation and quality of life. However, few studies have analyzed the possible determinants of sleep quality in the adult population as a whole, establishing patterns based on these.

Objective: To evaluate the determinants of sleep quality in a representative sample of the general adult population aged 25 to 65 years old and to establish patterns of sleep quality based on lifestyles, psychological factors, morbidities and biological markers.

Methodology:

Design: This is a descriptive observational, cross-sectional study that will include a representative sample of 500 people aged 25 to 65 years old from the city of Salamanca (Spain) selected by random sampling stratified by age and sex.

Study variables: A visit lasting approximately 90 minutes will be carried out. The determinants of sleep quality will be assessed using both objective and self-reported methods. Variables related to life styles will be assessed: physical activity, diet and toxic habits including tobacco smoking or alcohol use. Morbidity data will also be collected, and psychological factors such as anxiety will also be assessed. Serum melatonin levels will be determined as a biological marker related to sleep quality.

Detailed Description

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Conditions

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Sleep Quality

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Age 25-65 years old
* Sign the informed consent

Exclusion Criteria

* Patients with terminal disease
* Any clinical condition that would interfere with study procedures
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gerencia Regional de Salud de Castilla y Leon

OTHER

Sponsor Role collaborator

Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role collaborator

University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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José Ignacio Recio Rodriguez

PhD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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José Ignacio Recio Rodriguez

Salamanca, Salamanca, Spain

Site Status

Countries

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Spain

References

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Jimenez-Vaquero C, Alonso-Dominguez R, Garcia-Yu IA, Martin-Nogueras AM, Sanchez-Aguadero N, Crespo-Sedano A, Rihuete-Galve MI, Garcia-Alonso MA, Garcia-Prieto ML, Gonzalez-Sanchez J, Recio JI. Analysis of the determinants of sleep quality in a Spanish population: a study protocol for a cross-sectional study. BMJ Open. 2023 Mar 8;13(3):e069444. doi: 10.1136/bmjopen-2022-069444.

Reference Type DERIVED
PMID: 36889827 (View on PubMed)

Other Identifiers

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GRS 2320/A/21

Identifier Type: -

Identifier Source: org_study_id

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