Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus

January 9, 2023 updated by: Amal Mohamed Abdelwahab, Sohag University

Sleep is an important health behavior for children and adolescents due to the impact it has on both mental and physical development. Although sleep is considered a resting period, it is also a period when the brain work to encode and consolidate memories into more stable representations for long term recall . Unfortunately, pediatric sleep disorders affect 25 - 40% of youth and several studies showed that children with chronic illness experience more problems with initiating and maintaining sleep than their non- chronically ill children .

Type 1 diabetes mellitus (T1DM) affects the quality of sleep in children and adolescents as well as their caregivers. Sleep disturbances in patients with T1DM may negatively impact their ability to manage their diabetes .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: safaa H Ali, associate professor
  • Phone Number: 01064818849

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children and adolescents aged 6 to 15 years diagnosed with T1DM for at least 6 months and attending the pediatric diabetes outpatient clinic at Sohag University Hospital will be included in the study.

Age and sex matched control group will be included from children and adolescents attending the general pediatric outpatient clinic at Sohag University hospital for acute non-serious illnesses.

Description

Inclusion Criteria:

  • Children and adolescents aged 6 to 15 years .
  • diagnosed with T1DM for at least 6 months
  • attending the pediatric diabetes outpatient clinic at Sohag University Hospital.
  • Age and sex matched control group for acute non-serious illnesses

Exclusion Criteria:

  • Children and adolescents with associated neurological or psychiatric disorders .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diabetes children
Other: questionnaire about sleep quality in diabetic children
Pittsburgh sleep quality index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of nighttime sleep in hours in night times and weekends
Time Frame: in the past month
duration of nighttime sleep in hours in night times and weekends
in the past month
sleep problems as frequent awakening during the night
Time Frame: in the past month
sleep problems as frequent awakening during the night
in the past month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Estimate)

January 16, 2023

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-22-12-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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