Determinants of Sleep Quality in Spanish Population (SSQD Study)

Sleep Quality Clinical Trial

— SSQD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324267
• Other study ID #: GRS 2320/A/21
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: University of Salamanca
• Contact: Jose Ignacio Recio Rodriguez, PhD
• Phone: +34923294500
• Email: donrecio[@]usal.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Quality

Locations

Country	Name	City	State
Spain	José Ignacio Recio Rodriguez	Salamanca

Sponsors (3)

Lead Sponsor	Collaborator
University of Salamanca	Gerencia Regional de Salud de Castilla y León, Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep quality	Measured by accelerometer (Actigraph GT3X). This device reports Total Sleep Time (TST) measured in minutes.	Baseline
Primary	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	Physical activity	Measured by accelerometer (Actigraph GT3X). This device reports physical activity measured in steps per hour.	Baseline
Secondary	Diet	Measured by the Mediterranean Diet Adherence Screener (MEDAS). Possible scores range from 0 (lower adherence) to 14 (higher adherence).	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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