NCT05324267

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

April 4, 2022

Last Update Submit

October 18, 2024

Conditions

Sleep Quality

Keywords

Life StylePsychological FactorsMelatonin

Outcome Measures

Primary Outcomes (2)

  • Sleep quality

    Measured by accelerometer (Actigraph GT3X). This device reports Total Sleep Time (TST) measured in minutes.

    Baseline

  • Sleep quality

    Measured by the Pittsburgh Sleep Quality Index (PSQI). Possible scores on the PSQI range from 0 (no difficulty) to 21 (severe difficulties in all areas).

    Baseline

Secondary Outcomes (6)

  • Physical activity

    Baseline

  • Diet

    Baseline

  • Tobacco smoking

    Baseline

  • Alcohol use

    Baseline

  • Anxiety

    Baseline

  • +1 more secondary outcomes

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will include participants affiliated with the Health Service of Castilla y León (SACYL) (Spain) who meet all the eligibility criteria and none of the exclusion criteria.

You may qualify if:

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

You may not qualify if:

  • Patients with terminal disease
  • Any clinical condition that would interfere with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

José Ignacio Recio Rodriguez

Salamanca, Salamanca, 37005, Spain

Location

Related Publications (3)

  • Jimenez-Vaquero C, Gonzalez-Sanchez J, Alonso-Dominguez R, Garcia-Yu IA, Sanchez-Aguadero N, Crespo-Sedano A, Rihuete-Galve MI, Recio-Rodriguez JI. Sleep quality in Spanish adults: an age- and sex-stratified cross-sectional study. Sci Rep. 2025 Dec 12;15(1):43670. doi: 10.1038/s41598-025-27418-7.

    PMID: 41387971DERIVED

  • Jimenez-Vaquero C, Gonzalez-Sanchez J, Alonso-Dominguez R, Garcia-Yu IA, Sanchez-Aguadero N, Crespo-Sedano A, Rihuete-Galve MI, Recio-Rodriguez JI. Sex-specific sleep profiles in Spanish adults: cross-sectional actigraphy-PSQI study with cluster analysis in Salamanca and Avila. BMJ Open. 2025 Nov 4;15(11):e103094. doi: 10.1136/bmjopen-2025-103094.

    PMID: 41248358DERIVED

  • 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.

    PMID: 36889827DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate Professor

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 12, 2022

Study Start

June 1, 2022

Primary Completion

April 30, 2024

Study Completion

August 31, 2024

Last Updated

October 22, 2024

Record last verified: 2024-10

Locations

ES(1)