Determinants of Sleep Quality in Spanish Population (SSQD Study) (SSQD)

Analysis of the Determinants of Sleep Quality in a Spanish Population. A Study Protocol for a Cross-sectional Study

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Quality

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jose Ignacio Recio Rodriguez, PhD; Phone Number: 3108 +34923294500; Email: donrecio@usal.es

Study Locations

• Spain
  • Salamanca, Spain, 37005
    • Recruiting
    • José Ignacio Recio Rodriguez
    • Contact: José Ignacio Recio Rodriguez, PhD; Phone Number: 650330694; Email: donrecio@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	Measured by accelerometer (Actigraph GT3X). This device reports physical activity measured in steps per hour.	Baseline
Diet	Measured by the Mediterranean Diet Adherence Screener (MEDAS). Possible scores range from 0 (lower adherence) to 14 (higher adherence).	Baseline
Tobacco smoking	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.	Baseline
Alcohol use	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.	Baseline
Anxiety	Measured by the Generalized Anxiety Disorder (GAD-7) questionnaire. Possible scores range from 0 to 21. Increasing scores indicate higher levels of anxiety.	Baseline
Serum melatonin levels	Serum melatonin levels (measured in pg/ml) will be determined by high performance liquid chromatography-triple quadrupole mass spectrometry (HPLC-MS/MS triple quadrupole).	Baseline

Collaborators and Investigators

• Sponsor: University of Salamanca
• Collaborators: Instituto de Investigación Biomédica de Salamanca; Gerencia Regional de Salud de Castilla y Leon

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Melatonin; Life Style; Psychological Factors
• Other Study ID Numbers: GRS 2320/A/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No