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Completed

NCT Number: NCT05324267

Determinants of Sleep Quality in Spanish Population (SSQD 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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

José Ignacio Recio Rodriguez

Salamanca, 37005, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sleep quality

    Time frame: Baseline

    Measured by accelerometer (Actigraph GT3X). This device reports Total Sleep Time (TST) measured in minutes.

  2. Sleep quality

    Time frame: 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 outcomes

  1. Physical activity

    Time frame: Baseline

    Measured by accelerometer (Actigraph GT3X). This device reports physical activity measured in steps per hour.

  2. Diet

    Time frame: Baseline

    Measured by the Mediterranean Diet Adherence Screener (MEDAS). Possible scores range from 0 (lower adherence) to 14 (higher adherence).

  3. Tobacco smoking

    Time frame: 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.

  4. Alcohol use

    Time frame: 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.

  5. Anxiety

    Time frame: Baseline

    Measured by the Generalized Anxiety Disorder (GAD-7) questionnaire. Possible scores range from 0 to 21. Increasing scores indicate higher levels of anxiety.

  6. Serum melatonin levels

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Collaborators

  • Gerencia Regional de Salud de Castilla y Leon
  • Instituto de Investigación Biomédica de Salamanca

Registry information

Official study title

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

Acronym: SSQD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2022
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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