Evaluation of the Sleep Hygiene in the Lebanese Populatio... | NCT04372043

Studies
Evaluation of the Sleep Hygiene in the Lebanese Population During the COVID-19 Confinement Period.

NCT04372043

Sponsor

Saint-Joseph University

Status

Unknown status

Last Update Posted

May 1, 2020Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Sleep Hygiene

Interventions

Questionnaire

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2020Estimated

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Sep 30, 2020Estimated

First Submitted Date

Apr 29, 2020

First Submission Date that Met QC Criteria

Apr 29, 2020

First Posted Date

May 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2020

Last Update Posted Date

May 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lebanese population		The "Sleep Hygiene Index" with other demographic questions will be applied to the Lebanese population.	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	"Sleep Hygiene Index" and demographic questions.	Lebanese population

Measure	Description	Time Frame
Sleep Hygiene		30/04/2020 to 30/12/2020

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lebanese living in Lebanon, 18 YO and over, understanding written english or arabic.

Exclusion Criteria:

Not having the inclusion criteria.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

The Lebanese population living in Lebanon during the confinement period of the COVID-19 pandemic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeanine El Helou, MD, MSc	Contact	9613262586		jeanine.helouelsaliba@usj.edu.lb
Jad Costa	Contact			costajad@hotmail.com

Overall Officials

Name	Affiliation	Role
Jeanine El Helou, MD, MSc	USJ	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Joseph University		Beirut		1100	Lebanon

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Will check with the USJ board

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070263	Sleep Hygiene

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided