Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus

NCT ID: NCT05686655

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-02-01

Brief Summary

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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 .

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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diabetes children

questionnaire about sleep quality in diabetic children

Intervention Type OTHER

Pittsburgh sleep quality index

Interventions

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questionnaire about sleep quality in diabetic children

Pittsburgh sleep quality index

Intervention Type OTHER

Eligibility Criteria

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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 .
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Amal Mohamed Abdelwahab

resident at pediatric departement at el helal hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Aml M Abdel wahab, resident

Role: CONTACT

01148212777

safaa H Ali, associate professor

Role: CONTACT

01064818849

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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Reutrakul S, Thakkinstian A, Anothaisintawee T, Chontong S, Borel AL, Perfect MM, Janovsky CC, Kessler R, Schultes B, Harsch IA, van Dijk M, Bouhassira D, Matejko B, Lipton RB, Suwannalai P, Chirakalwasan N, Schober AK, Knutson KL. Sleep characteristics in type 1 diabetes and associations with glycemic control: systematic review and meta-analysis. Sleep Med. 2016 Jul;23:26-45. doi: 10.1016/j.sleep.2016.03.019. Epub 2016 Jun 8.

Reference Type BACKGROUND
PMID: 27692274 (View on PubMed)

Monzon A, McDonough R, Meltzer LJ, Patton SR. Sleep and type 1 diabetes in children and adolescents: Proposed theoretical model and clinical implications. Pediatr Diabetes. 2019 Feb;20(1):78-85. doi: 10.1111/pedi.12797. Epub 2018 Dec 4.

Reference Type BACKGROUND
PMID: 30447038 (View on PubMed)

Turner SL, Queen TL, Butner J, Wiebe D, Berg CA. Variations in Daily Sleep Quality and Type 1 Diabetes Management in Late Adolescents. J Pediatr Psychol. 2016 Jul;41(6):661-9. doi: 10.1093/jpepsy/jsw010. Epub 2016 Mar 19.

Reference Type BACKGROUND
PMID: 26994852 (View on PubMed)

Suleiman KH, Yates BC, Berger AM, Pozehl B, Meza J. Translating the Pittsburgh Sleep Quality Index into Arabic. West J Nurs Res. 2010 Mar;32(2):250-68. doi: 10.1177/0193945909348230. Epub 2009 Nov 14.

Reference Type BACKGROUND
PMID: 19915205 (View on PubMed)

Other Identifiers

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soh-Med-22-12-05

Identifier Type: -

Identifier Source: org_study_id

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