AzTrials
AzTrials

Sleep QualitySSQDNCT05324267

Determinants of Sleep Quality in Spanish Population (SSQD Study)

An observational study of Sleep Quality, run by University of Salamanca at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Quality
How many people
500 participants
Where
1 siteSpain
Study dates
1 Jun 2022to 31 Aug 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • Age 25-65 years old
  • Sign the informed consent

Who cannot join

  • Patients with terminal disease
  • Any clinical condition that would interfere with study procedures

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • José Ignacio Recio Rodriguez

    Salamanca, Salamanca, 37005

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Conditions
Sleep Quality
Keywords
Life Style, Psychological Factors, Melatonin
Medical subject headings
Sleep Initiation and Maintenance Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep quality

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

    Measured: Baseline

  2. 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).

    Measured: Baseline

Secondary outcomes (6)

  1. Physical activity

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

    Measured: Baseline

  2. Diet

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

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. Anxiety

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

    Measured: Baseline

  6. 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).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start1 Jun 2022
  3. Primary completion30 Apr 2024
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05324267
Sponsor's protocol ID
GRS 2320/A/21
Acronym
SSQD
Status last verified
Oct 2024
First submitted
4 Apr 2022
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jimenez-Vaquero C, Gonzalez-Sanchez J, Alonso-Dominguez R, Garcia-Yu IA, Sanchez-Aguadero N, Crespo-Sedano A, Rihuete-Galve MI, Recio-Rodriguez JI. Sleep quality in Spanish adults: an age- and sex-stratified cross-sectional study. Sci Rep. 2025 Dec 12;15(1):43670. doi: 10.1038/s41598-025-27418-7.

    PubMed 41387971

  • Jimenez-Vaquero C, Gonzalez-Sanchez J, Alonso-Dominguez R, Garcia-Yu IA, Sanchez-Aguadero N, Crespo-Sedano A, Rihuete-Galve MI, Recio-Rodriguez JI. Sex-specific sleep profiles in Spanish adults: cross-sectional actigraphy-PSQI study with cluster analysis in Salamanca and Avila. BMJ Open. 2025 Nov 4;15(11):e103094. doi: 10.1136/bmjopen-2025-103094.

    PubMed 41248358

  • Jimenez-Vaquero C, Alonso-Dominguez R, Garcia-Yu IA, Martin-Nogueras AM, Sanchez-Aguadero N, Crespo-Sedano A, Rihuete-Galve MI, Garcia-Alonso MA, Garcia-Prieto ML, Gonzalez-Sanchez J, Recio JI. Analysis of the determinants of sleep quality in a Spanish population: a study protocol for a cross-sectional study. BMJ Open. 2023 Mar 8;13(3):e069444. doi: 10.1136/bmjopen-2022-069444.

    PubMed 36889827

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Quality, run by University of Salamanca at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep quality (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05324267, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in