The Effect of Sleep hygıene traınıng on Blood Sugar regulatıon

NCT04918004 | Completed

• 1 other identifier: 27.11.2017 - 43/06
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Sleep Hygiene

Keywords

Diabetes Mellitus Type 2; Sleep Hygiene; Treatment

Outcome Measures

Primary Outcomes (2)

• Pıttsburgh Sleep Quality Index Score

  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.

  Within 3-6 months after first visit

• Hba1c mmol/mol

  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 .

  Within 3-6 months after first visit

Study Arms (2)

Case group

EXPERIMENTAL

Patients in the case group were given one-to-one sleep hygiene training by researchers and, a brochure containing 10 lifestyle changes related to sleep hygiene as well as they assessed at the first interview and the last interview, received routine health care, and

Behavioral: Sleep Hygiene

Control group

NO INTERVENTION

Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research.

Interventions

Sleep Hygiene BEHAVIORAL

1. One-to-one sleep hygiene training, the content of which was created by the researchers, 2. A brochure containing 10 lifestyle changes related to sleep hygiene

Case group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

University of Health Sciences Turkey Ankara Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, Altındağ, 06110, Turkey (Türkiye)

Location

Related Publications (10)

• Kachi Y, Nakao M, Takeuchi T, Yano E. Association between insomnia symptoms and hemoglobin A1c level in Japanese men. PLoS One. 2011;6(7):e21420. doi: 10.1371/journal.pone.0021420. Epub 2011 Jul 1.

  PMID: 21747936 BACKGROUND

• Tan X, van Egmond L, Chapman CD, Cedernaes J, Benedict C. Aiding sleep in type 2 diabetes: therapeutic considerations. Lancet Diabetes Endocrinol. 2018 Jan;6(1):60-68. doi: 10.1016/S2213-8587(17)30233-4. Epub 2017 Aug 24.

  PMID: 28844889 BACKGROUND

• Nedeltcheva AV, Scheer FA. Metabolic effects of sleep disruption, links to obesity and diabetes. Curr Opin Endocrinol Diabetes Obes. 2014 Aug;21(4):293-8. doi: 10.1097/MED.0000000000000082.

  PMID: 24937041 BACKGROUND

• Spiegel K, Tasali E, Leproult R, Van Cauter E. Effects of poor and short sleep on glucose metabolism and obesity risk. Nat Rev Endocrinol. 2009 May;5(5):253-61. doi: 10.1038/nrendo.2009.23.

  PMID: 19444258 BACKGROUND

• Lee SWH, Ng KY, Chin WK. The impact of sleep amount and sleep quality on glycemic control in type 2 diabetes: A systematic review and meta-analysis. Sleep Med Rev. 2017 Feb;31:91-101. doi: 10.1016/j.smrv.2016.02.001. Epub 2016 Feb 9.

  PMID: 26944909 BACKGROUND

• Smyth A, Jenkins M, Dunham M, Kutzer Y, Taheri S, Whitehead L. Systematic review of clinical practice guidelines to identify recommendations for sleep in type 2 diabetes mellitus management. Diabetes Res Clin Pract. 2020 Dec;170:108532. doi: 10.1016/j.diabres.2020.108532. Epub 2020 Nov 4.

  PMID: 33157114 BACKGROUND

• Zhu B, Hershberger PE, Kapella MC, Fritschi C. The relationship between sleep disturbance and glycaemic control in adults with type 2 diabetes: An integrative review. J Clin Nurs. 2017 Dec;26(23-24):4053-4064. doi: 10.1111/jocn.13899. Epub 2017 Jul 17.

  PMID: 28544107 BACKGROUND

• Chasens ER, Korytkowski M, Sereika SM, Burke LE. Effect of poor sleep quality and excessive daytime sleepiness on factors associated with diabetes self-management. Diabetes Educ. 2013 Jan-Feb;39(1):74-82. doi: 10.1177/0145721712467683. Epub 2012 Nov 27.

  PMID: 23192600 BACKGROUND

• Seibert PS, Valerio J, DeHaas C. The concomitant relationship shared by sleep disturbances and type 2 diabetes: developing telemedicine as a viable treatment option. J Diabetes Sci Technol. 2013 Nov 1;7(6):1607-15. doi: 10.1177/193229681300700621.

  PMID: 24351187 BACKGROUND

• Larcher S, Benhamou PY, Pepin JL, Borel AL. Sleep habits and diabetes. Diabetes Metab. 2015 Sep;41(4):263-271. doi: 10.1016/j.diabet.2014.12.004. Epub 2015 Jan 23.

  PMID: 25623152 BACKGROUND

Related Links

• TEMD Diabetes Mellitus Çalışma ve Eğitim Grubu, Diagnosis and Monitoring Guide for Diabetes Mellitus and Its Complications 2020 Türkiye Endokrinoloji ve Metabolizma Derneği: 2020. p.40-44
• Agargün M Y, Kara H, Anlar O (1996) Validity and Reliability of Pittsburgh Sleep Quality. Türk Psikiyatri Dergisi, 7: 107-115.
• TurcosaAnalytics (2021). TURCOSA \[Cloud-based statistical software\].

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sleep Hygiene

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Health Behavior; Behavior

Study Officials

• Süleyman Görpelioğlu, Prof.Dr.

  Academic staff

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 8, 2021
• Study Start: January 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: November 30, 2018
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)