Clinical trial NCT04918004: The Effect of Sleep hygıene traınıng on Blood Sugar regulatıon
Official title: The Effect of Sleep hygıene traınıng gıven to patıents wıth dıabetes mellıtus on Blood Sugar regulatıon: a randomızed Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sleep Hygiene
Keywords: Diabetes Mellitus Type 2
Sleep Hygiene
Treatment
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-06-08
Enrollment: 347
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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 :

* Enter the bed when you feel sleepy. If you lie in bed for more than half an hour, get out of bed. When you feel sleepy, go back to bed
* Do not sleep more than 1 hour during the day time.
* Avoid heavy and fatty meals in the evening, do not go to bed very hungry or very satiated. Avoid beverages such as coffee, tea, coke, energy drinks and alcohol.
* Exercise or walk regularly in the evening, but avoid physically strenuous activities 3-4 hours before bedtime
* In order for your body clock to work properly, live regularly. Get out of bed at the same time everyday. Wake up at the time you should wakeup in the morning, even if you went to bed at a different time of the night. Follow this rule, even on the weekend, and make it a habit to always get up at the same time. Sleeping and awakening times are important in maintaining sleep patterns.
* Use the bed for sleep purposes only. Do not do activities such as eating, watching TV, reading a book, or planning the next day in bed.
* Make sure your bedroom is quiet and dark
* Avoid exciting activities such as watching horror movies or reading adventure boks before going to bed
* Try to avoid a stressful life.
* Never take sleeping pills without your doctor's knowledge.

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.

Eligibility criteria: Inclusion Criteria:

* Patients who were admitted to our clinic with the diagnosis of diabetes mellitus type 2 during the study

Exclusion Criteria:

* Patients with a known sleep disorder,
* Language or psychiatric problems that prevented responding to the questionnaire
* Patients who underwent changes in their antidiabetic treatment during the first control examination
* Those who did not re-admit to the hospital for routine check-ups within 6 months after the first visit
* Patients who declared not to comply with the recommendations were excluded from the study

Primary outcomes:
measure: Pıttsburgh Sleep Quality Index Score
timeFrame: Within 3-6 months after first visit
measure: Hba1c mmol/mol
timeFrame: Within 3-6 months after first visit
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Turkey Ankara Diskapi Yildirim Beyazit Training and Research Hospital
state: Altındağ
Study officials:
affiliation: Academic staff
name: Süleyman Görpelioğlu, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
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