Sleep QualityNCT07043530
Effect of a Sleep Hygiene-based Intervention on Sleep Quality and Mental Health in Medical Students
A study testing In-person sleep hygiene-based intervention and Online sleep hygiene-based intervention in people with Sleep Quality and Mental Health, run by Universidad Autónoma de Yucatán at 1 site in Mexico.
Trial summary
The aim of the study is to investigate whether an online sleep hygiene programm is as effective as a face-to-face programm in improving sleep quality and mental health in medical students. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Quality, Mental Health, Students, Medical
- What is being tested?
- In-person sleep hygiene-based intervention and Online sleep hygiene-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being a medical student enrolled in the Universidad Autonoma de Yucatan.
- Having poor sleep quality according to the Pittsburgh Sleep Quality Index.
- Having at least one electronic device with Internet access.
- Having time availability.
- Having signed the informed consent.
Who cannot join
- Being in their year of Internship or Social Service.
- Being pregnant.
- Having children of any age.
- Being under psychological therapy.
- Regulary consuming sleep, depression or anxiety medication.
- Working the night shift.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Héctor A Rubio-Zapata, Dr. contact
Mexico1 site
Universidad Autónoma de Yucatán
Mérida
Héctor A Rubio-Zapata, Dr., +529999240554, hector.rubio@correo.uady.mx
About this study
Official title: Effect of a Sleep Hygiene-based Intervention on Sleep Quality and Mental Health in Medical Students: a Comparison Between In-person and Online Learning
The aim of the study is to investigate whether an online sleep hygiene programm is as effective as a face-to-face programm in improving sleep quality and mental health in medical students.
- Conditions
- Sleep Quality, Mental Health, Students, Medical
- Being tested
- In-person sleep hygiene-based intervention, Online sleep hygiene-based intervention
- Keywords
- Sleep hygiene, Sleep quality, Mental health, Medical students, Online intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychological Well-Being, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person sleep hygiene-based interventionBehavioural
The in-person sleep hygiene-based intervention will be delivered in 8 sessions by an sleep expert using digital resources, previously designed and expert validated. During the intervention, the following topics will be covered: (1) sleep hygiene generalities, (2) sleep and environment, (3) sleep and technology, (4) sleep and diet, (5) sleep and excercise, (6) sleep and stimulus control, (7) breathing techniques, (8) mindfulness. The sessions will be delivered twice a week with an approximated duration of 45 minutes each, until completed.
Online sleep hygiene-based interventionBehavioural
The online sleep hygiene-based intervention will be delivered in 8 sessions through a self-paced educational platform; the content will be the same as in the in-person intervention, but tailored for use in digital learning platforms. The suggest completion time for each session will be 45 minutes. Although its self-paced nature, participants are required to complete it within one month, following the same timeline as the face-to-face arm.
| Study group | Role | What they receive |
|---|---|---|
| In-person intervention | Active comparator | Not described Receives: Behavioral: In-person sleep hygiene-based intervention |
| Online intervention | Experimental | Not described Receives: Behavioral: Online sleep hygiene-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
This outcome will be measured by means of the Pittsburgh Sleep Quality Index, which is a self-administered 19-item questionnaire regarding perceived sleep quality, sleep latency, sleep duration, sleep efficiency, sleep alterations, sleep medication use and daytime sleepiness. A score under 6 points suggests good sleep quality, while a score greater or equal to 6 point suggests poor sleep quality.
Measured: 6 months
Mental health
This outcome will be measured by means of the Positive Mental Health Scale (PMHS) and Symptom Checklist 90 Revised (SCL-90-R). The PMHS is a self-administered 83-item questionnaire regarding cognitive and emotional well-being, environmental mastery, social abilities, social sensitivity and empathy, physical well-being, self-reflection, psychological discomfort. The minimum score is 83 and the maximum score is 415; a higher score mean higher positive mental health.
The SCL-90-R is a self-administered 90-item questionnaire regarding somatization, obssesive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism. Each dimension is independently scored, with a higher grade meaning the pressence of psychological disorders in the evaluated dimension.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Yucatán
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Morales-Robles, Universidad Autónoma de Yucatán
- Investigators
- Héctor A Rubio-Zapata, Dr., Study director, Universidad Autónoma de YucatánDamaris F Estrella-Castillo, Dr., Study director, Universidad Autónoma de Yucatán
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043530
- Sponsor's protocol ID
- Fmed-07-25
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Sleep Hygiene-based Intervention on Sleep Quality and Mental Health in Medical Students: a Comparison Between In-person and Online Learning
- ClinicalTrials.gov ID
- NCT07043530
- Acronym / sponsor ID
- Fmed-07-25
- Conditions
- Sleep Quality, Mental Health, Students, Medical
- Keywords
- Sleep hygiene, Sleep quality, Mental health, Medical students, Online intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Universidad Autónoma de YucatánUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate whether an online sleep hygiene programm is as effective as a face-to-face programm in improving sleep quality and mental health in medical students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person intervention | Active comparator | Behavioral: In-person sleep hygiene-based intervention |
| Online intervention | Experimental | Behavioral: Online sleep hygiene-based intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being a medical student enrolled in the Universidad Autonoma de Yucatan.
- Having poor sleep quality according to the Pittsburgh Sleep Quality Index.
- Having at least one electronic device with Internet access.
- Having time availability.
- Having signed the informed consent.
Key exclusion criteria (6 listed)
- Being in their year of Internship or Social Service.
- Being pregnant.
- Having children of any age.
- Being under psychological therapy.
- Regulary consuming sleep, depression or anxiety medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person sleep hygiene-based interventionThe in-person sleep hygiene-based intervention will be delivered in 8 sessions by an sleep expert using digital resources, previously designed and expert validated. During the intervention, the following topics will be covered: (1) sleep hygiene generalities, (2) sleep and environment, (3) sleep and technology, (4) sleep and diet, (5) sleep and excercise, (6) sleep and stimulus control, (7) breathing techniques, (8) mindfulness. The sessions will be delivered twice a week with an approximated duration of 45 minutes each, until completed. | Behavioural | In-person intervention |
| Online sleep hygiene-based interventionThe online sleep hygiene-based intervention will be delivered in 8 sessions through a self-paced educational platform; the content will be the same as in the in-person intervention, but tailored for use in digital learning platforms. The suggest completion time for each session will be 45 minutes. Although its self-paced nature, participants are required to complete it within one month, following the same timeline as the face-to-face arm. | Behavioural | Online intervention |
Primary outcome
Sleep quality
Time frame: 6 months
This outcome will be measured by means of the Pittsburgh Sleep Quality Index, which is a self-administered 19-item questionnaire regarding perceived sleep quality, sleep latency, sleep duration, sleep efficiency, sleep alterations, sleep medication use and daytime sleepiness. A score under 6 points suggests good sleep quality, while a score greater or equal to 6 point suggests poor sleep quality.
Mental health
Time frame: 6 months
This outcome will be measured by means of the Positive Mental Health Scale (PMHS) and Symptom Checklist 90 Revised (SCL-90-R). The PMHS is a self-administered 83-item questionnaire regarding cognitive and emotional well-being, environmental mastery, social abilities, social sensitivity and empathy, physical well-being, self-reflection, psychological discomfort. The minimum score is 83 and the maximum score is 415; a higher score mean higher positive mental health. The SCL-90-R is a self-administered 90-item questionnaire regarding somatization, obssesive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism. Each dimension is independently scored, with a higher grade meaning the pressence of psychological disorders in the evaluated dimension.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Héctor A Rubio-Zapata, Dr. contact
Héctor A Rubio-Zapata, Dr. study director
Universidad Autónoma de Yucatán
Damaris F Estrella-Castillo, Dr. study director
Universidad Autónoma de Yucatán
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person sleep hygiene-based intervention and Online sleep hygiene-based intervention in people with Sleep Quality and Mental Health, run by Universidad Autónoma de Yucatán at 1 site in Mexico.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Jun 2025. 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Morales-Robles, M.Sc. (+529993630074, andreamoralesrobles@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: 6 months). 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?
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 29 Jun 2025.