Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05686655 |
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Recruitment Status :
Not yet recruiting
First Posted : January 16, 2023
Last Update Posted : January 16, 2023
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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 .
| Condition or disease | Intervention/treatment |
|---|---|
| Diabetes Mellitus, Type 1 | Other: questionnaire about sleep quality in diabetic children |
| Study Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Cross-Sectional |
| Official Title: | Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus |
| Estimated Study Start Date : | February 1, 2023 |
| Estimated Primary Completion Date : | February 1, 2024 |
| Estimated Study Completion Date : | February 1, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
| diabetes children |
Other: questionnaire about sleep quality in diabetic children
Pittsburgh sleep quality index |
- 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
- sleep problems as frequent awakening during the night [ Time Frame: in the past month ]sleep problems as frequent awakening during the night
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 6 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Probability Sample |
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.
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 .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05686655
| Contact: Aml M Abdel wahab, resident | 01148212777 | aml011055@med.sohag.edu.eg | |
| Contact: safaa H Ali, associate professor | 01064818849 |
| Egypt | |
| Sohag University Hospital | |
| Sohag, Egypt | |
| Contact: Magdy M Amin, professor | |
| Responsible Party: | Amal Mohamed Abdelwahab, resident at pediatric departement at el helal hospital, Sohag University |
| ClinicalTrials.gov Identifier: | NCT05686655 |
| Other Study ID Numbers: |
soh-Med-22-12-05 |
| First Posted: | January 16, 2023 Key Record Dates |
| Last Update Posted: | January 16, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |