Sleep HygieneNCT04372043
Evaluation of the Sleep Hygiene in the Lebanese Population During the COVID-19 Confinement Period.
An observational study of Sleep Hygiene, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
The term "sleep hygiene" refers to a series of healthy sleep habits that can improve the ability to fall asleep. These habits are the most effective long-term treatment for people with chronic insomnia. The "Sleep Hygiene Index" is a 13-item questionnaire that evaluates these habits. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Hygiene
- What is being tested?
- Questionnaire
- How many people
- 1,200 participants
- Where
- 1 siteLebanon
- Study dates
- 30 Apr 2020to 30 Sep 2020
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Lebanese population living in Lebanon during the confinement period of the COVID-19 pandemic.
Who may be able to join
- Lebanese living in Lebanon, 18 YO and over, understanding written english or arabic.
Who cannot join
- Not having the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Jad Costa contact
Lebanon1 site
Saint Joseph University
Beirut, 1100
Jeanine El Helou, MD, MSc, jeanine.helouelsaliba@usj.edu.lb
Jeanine El Helou, MD, MSc
About this study
The term "sleep hygiene" refers to a series of healthy sleep habits that can improve the ability to fall asleep. These habits are the most effective long-term treatment for people with chronic insomnia. The "Sleep Hygiene Index" is a 13-item questionnaire that evaluates these habits. We are in the process of validation of this questionnaire in the arabic language.
We will evaluate these habits in the Lebanese population during the COVID-19 confinement period.
Read the detailed description
The sleep hygiene will be evaluated during the COVID-19 confinement period. The "Sleep Hygiene Index" with other questions will be applied to the Lebanese population in english and arabic. It will be distributed by the means of WhatsApp and Facebook.
- Conditions
- Sleep Hygiene
- Being tested
- Questionnaire
- Medical subject headings
- Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
"Sleep Hygiene Index" and demographic questions.
| Study group | Role | What they receive |
|---|---|---|
| Lebanese population | The "Sleep Hygiene Index" with other demographic questions will be applied to the Lebanese population. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Hygiene
Measured: 30/04/2020 to 30/12/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start30 Apr 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep HygieneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanine El Helou, MD, MSc, Study chair, USJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372043
- Sponsor's protocol ID
- CEHDF1650
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will check with the USJ board
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sleep Hygiene in the Lebanese Population During the COVID-19 Confinement Period.
- ClinicalTrials.gov ID
- NCT04372043
- Acronym / sponsor ID
- CEHDF1650
- Conditions
- Sleep Hygiene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 30 Apr 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 1 May 2020 (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 term "sleep hygiene" refers to a series of healthy sleep habits that can improve the ability to fall asleep. These habits are the most effective long-term treatment for people with chronic insomnia. The "Sleep Hygiene Index" is a 13-item questionnaire that evaluates these habits. We are in the process of validation of this questionnaire in the arabic language.
We will evaluate these habits in the Lebanese population during the COVID-19 confinement period.
Detailed description
The sleep hygiene will be evaluated during the COVID-19 confinement period. The "Sleep Hygiene Index" with other questions will be applied to the Lebanese population in english and arabic. It will be distributed by the means of WhatsApp and Facebook.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lebanese population | – | Other: QuestionnaireThe "Sleep Hygiene Index" with other demographic questions will be applied to the Lebanese population. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Lebanese population living in Lebanon during the confinement period of the COVID-19 pandemic.
Key inclusion criteria (1 listed)
- Lebanese living in Lebanon, 18 YO and over, understanding written english or arabic.
Key exclusion criteria (1 listed)
- Not having the inclusion criteria.
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 |
|---|---|---|
| Questionnaire"Sleep Hygiene Index" and demographic questions. | Other | Lebanese population |
Primary outcome
Sleep Hygiene
Time frame: 30/04/2020 to 30/12/2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Individual participant dataSharing planned: Undecided. Will check with the USJ board
Related trials for Sleep Hygiene
Not yet recruiting
AI-Powered Sleep Hygiene Mentor for Adults Living With HIV
Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
Not yet recruitingEarly Phase 1
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Sleep, Circadian Dysregulation
Recruiting
Sleep Better, Live Better Study
Sleep Hygiene, Sleep Duration
Recruiting
Online Sleep Education for College Student's Sleep Health and Executive Functioning
Sleep, Executive Functioning
Not yet recruiting
A Theory-based Sleep Hygiene Education for Insomnia Disorder
Insomnia, Adults
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. This study is not recruiting at the moment.
Jad Costa contact
Jeanine El Helou, MD, MSc study chair
USJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Hygiene, run by Saint-Joseph University at 1 site in Lebanon.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 May 2020. 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 Lebanon. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeanine El Helou, MD, MSc (9613262586, jeanine.helouelsaliba@usj.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Hygiene (time frame: 30/04/2020 to 30/12/2020). 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 1 May 2020.