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Not yet recruitingNCT07043530Updated Jun 29, 2025

Effect of a Sleep Hygiene-based Intervention on Sleep Quality and Mental Health in Medical Students

An interventional study of In-person sleep hygiene-based intervention and Online sleep hygiene-based intervention in Sleep Quality, Mental Health and Students, Medical, sponsored by Universidad Autónoma de Yucatán. Not yet recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by Universidad Autónoma de Yucatán · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Quality
  • Mental Health
  • Students, Medical

Keywords

  • Sleep hygiene
  • Sleep quality
  • Mental health
  • Medical students
  • Online intervention
03

In context

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's planned enrollment of 78 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Universidad Autónoma de Yucatán is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • Active comparator
    In-person intervention

    Behavioral: In-person sleep hygiene-based intervention

  • Experimental
    Online intervention

    Behavioral: Online sleep hygiene-based intervention

Interventions

  • BehavioralIn-person sleep hygiene-based intervention

    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.

  • BehavioralOnline sleep hygiene-based intervention

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

Other outcomes

  1. Sleep hygiene

    This outcome will be evaluated using the Sleep Hygiene Index.

    Time frame: 6 months

07

Study locations

1 site
  • Universidad Autónoma de Yucatán
    Mérida, Mexico
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2025; primary completion for Jan 2026, 5 months later.

Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 5 months is below that.

Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 20, 2025
First posted
Jun 29, 2025
StartEst.
Aug 2025
Primary completionEst.
Jan 2026
CompletionEst.
Jul 2027
Last update
Jun 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07043530
Lead sponsor
Universidad Autónoma de Yucatán
Responsible party
Andrea Morales-Robles (Ph.D. student, Universidad Autónoma de Yucatán) — Principal investigator
First posted
Jun 29, 2025
Start date
Aug 2025 (estimated)
Primary completion
Jan 2026 (estimated)
Completion
Jul 2027 (estimated)
Last update
Jun 29, 2025

Study contacts

Andrea Morales-Robles, M.Sc.
Contact
andreamoralesrobles@outlook.com
+529993630074
Héctor A Rubio-Zapata, Dr.
Contact
hector.rubio@correo.uady.mx
Héctor A Rubio-Zapata, Dr.
study director · Universidad Autónoma de Yucatán
Damaris F Estrella-Castillo, Dr.
study director · Universidad Autónoma de Yucatán

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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