University of Health Sciences Turkey Ankara Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, Altındağ, 06110, Turkey (Türkiye)
NCT Number: NCT04918004
Although many studies have shown an inverse relationship between blood glucose regulation and sleep hygiene, recommendations for improving sleep hygiene have not yet been included in diabetes treatment guidelines. In this study, it was aimed to reveal with a randomized controlled study whether training on sleep hygiene will have an effect on blood glucose regulation of Type 2 diabetes patients. Case and control groups will be formed by random sampling method. Pıttsburgh sleep quality index will be applied face to face and HbA1c values will be recorded for all patients included in the study. In addition, sleep hygiene training will be given to the case group. Among the patients included in the study, the second HbA1c levels of those who came for routine diabetes control within six months will be recorded and the sleep hygiene education compliance scale will be applied to the case group. Differences between groups will be evaluated using chi-square and Student's t tests. According to the results of the research, it will be tried to decide whether sleep hygiene education can be used in the treatment of type 2 diabetes patients.
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Interventional
Not applicable
Ankara, Altındağ, 06110, Turkey (Türkiye)
Although there are many studies in the literature examining the relationship between diabetes mellitus and poor sleep quality, most of the studies are cross-sectional. While the relationship between sleep quality and blood glucose regulation was clearly shown in these studies, very few studies aimed to observe the effect of sleep quality correction on blood glucose regulation. As a result of this, of the 35 guidelines addressed in a meta-analysis conducted in 2020 only 14 guidelines included sleep in their recommendations, optimising sleep duration and quality and the management of sleep disorders were discussed as a therapeutic approach in 6 guidelines. In these also only 3 guidelines recommended optimal sleep duration as a therapeutic target of life style intervention and self-management education with one guideline identifying optimal sleep as a means of achieving glycaemic targets in T2DM .
In this randomised controlled study, it is aimed to provide evidence for the guidelines on the treatment of diabetes by demonstrating whether the education that includes simple lifestyle changes to increase sleep hygiene will have an effect on blood glucose regulation of Type 2 diabetes patients.
In the power analysis based on the tests to be used, when Type 1 error (α) = 0.05, Type 2 error (1-β) = 0.95, effect size is considered as 0.5; it was calculated that the sample size should be 210 (105 for each group) in total.
Patients with sleep disorders, language or psychiatric problems known to interfere with responding to the questionnaire, and patients whose antidiabetic treatment was changed at the first control examination will be excluded from the study.
In their first visit, the participants will be administered a routine diabetes control including HbA1c measurements, as well as a sociodemographic data collection questionnaire prepared by the researchers, a questionnaire consisting of 20 questions including questions about diabetes and sleep problems, and the Turkish version of the Pittsburgh Sleep Quality Index (PSQI) by face-to-face interview technique.
In addition, each patient included in the case group was given a brochure containing one-on-one sleep hygiene education and 10 lifestyle changes related to sleep hygiene, the content of which was created by the researchers.
Recommendations in the sleep hygiene leaflet :
At the next visit of all participants, a second visit PSQI will be administered in addition to HbA1c, and a statement-based "sleep hygiene education compliance questionnaire" will be administered to the case group, questioning whether they have complied with the items in the sleep hygiene education material recommended at the first interview.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Within 3-6 months after first visit
Pıttsburgh sleep quality index score was used in order to determine whether the training provided increases the sleep quality or not.An increase in the second measured index score compared to the first measured Pitssburg sleep quality index score will indicate a decrease in sleep quality.
Time frame: Within 3-6 months after first visit
To detect change in blood sugar regulation HbA1c values will be used. A decrease in the second measured HbA1c values compared to the first measured HbA1c values will indicate a positive effect on blood sugar regulation .
Diskapi Yildirim Beyazit Education and Research Hospital
Other Gov
The Effect of Sleep hygıene traınıng gıven to patıents wıth dıabetes mellıtus on Blood Sugar regulatıon: a randomızed Controlled Study
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