Determinants of Sleep Quality in Spanish Population (SSQD Study)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05324267

Acronym

SSQD

Enrollment

500

Registered

2022-04-12

Start date

2022-06-01

Completion date

2024-08-31

Last updated

2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Quality

Keywords

Life Style, Psychological Factors, Melatonin

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Sleep quality	Baseline	Measured by accelerometer (Actigraph GT3X). This device reports Total Sleep Time (TST) measured in minutes.

Secondary

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

Countries

Spain

Outcome results