Clinical trial NCT05324267: Determinants of Sleep Quality in Spanish Population (SSQD Study)
Official title: Analysis of the Determinants of Sleep Quality in a Spanish Population. a Study Protocol for a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Quality
Keywords: Life Style
Psychological Factors
Melatonin
Lead sponsor: University of Salamanca
Sponsor class: OTHER
Collaborators: name: Gerencia Regional de Salud de Castilla y Leon
name: Instituto de Investigación Biomédica de Salamanca
First posted: 2022-04-12
Enrollment: 500
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sleep quality
timeFrame: Baseline
measure: Sleep quality
timeFrame: Baseline
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline
measure: Diet
timeFrame: Baseline
measure: Tobacco smoking
timeFrame: Baseline
measure: Alcohol use
timeFrame: Baseline
measure: Anxiety
timeFrame: Baseline
measure: Serum melatonin levels
timeFrame: Baseline
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: José Ignacio Recio Rodriguez
Study officials:
References: