Determinants of Sleep Quality in Spanish Population (SSQD Study)

Completed

• Conditions: Sleep Quality

• Registration Number: NCT05324267
• Lead Sponsor: University of Salamanca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-12
• Study Start: 2022-06-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality	Baseline	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).

Secondary Outcome Measures

Name	Time	Method
Alcohol use	Baseline	Measured by the Alcohol Use Disorders Identification Test (AUDIT). Possible scores range from 0 to 40. An AUDIT score of 8 or more indicates hazardous or harmful alcohol use; a score of less than 8 indicates non-hazardous consumption.
Serum melatonin levels	Baseline	Serum melatonin levels (measured in pg/ml) will be determined by high performance liquid chromatography-triple quadrupole mass spectrometry (HPLC-MS/MS triple quadrupole).
Diet	Baseline	Measured by the Mediterranean Diet Adherence Screener (MEDAS). Possible scores range from 0 (lower adherence) to 14 (higher adherence).
Physical activity	Baseline	Measured by accelerometer (Actigraph GT3X). This device reports physical activity measured in steps per hour.
Tobacco smoking	Baseline	Measured by the Fagerström Test for Nicotine Dependence. This six-item questionnaire generates test scores ranging from 0 to 10, with higher scores indicating greater nicotine dependence.
Anxiety	Baseline	Measured by the Generalized Anxiety Disorder (GAD-7) questionnaire. Possible scores range from 0 to 21. Increasing scores indicate higher levels of anxiety.

Trial Locations

Locations (1)

José Ignacio Recio Rodriguez; 🇪🇸 Salamanca, Spain