Sleep Hygiene Education in Type 2 Diabetes

NCT07347964 | Completed

• 1 other identifier: 2021/18-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of sleep hygiene education on sleep quality and glycemic control of Type 2 Diabetes patients. Patients between the ages of 18-65, who were registered to the Gaziemir 11 No. Dokuz Eylül Education Family Health Centers and applied to the polyclinic, and had Type 2 Diabetes diagnosis for at least 1 year were included in the study. In the patient group in which the study will be conducted, the patients who will be applied the Pittsburgh Sleep Quality Index (PSQI) and those with a PSQI score of more than 5 were included in the study. A sociodemographic questionnaire was applied to the participants, the last measured HbA1c values were questioned, and fingertip fasting blood sugars were measured. Sleep hygiene training was applied to the intervention group at the first admission, a sleep hygiene rules checklist was given and they were asked to keep a two-week sleep diary. After the two-week sleep diary, the participants in the intervention group were given training on these issues by determining the things that could impair the quality of their sleep through the sleep diary they kept. Sleep training and sleep hygiene rules checklist were given to the control group after three months of follow-up. At the end of the 3-month follow-up, PSQI was applied to both groups again, and the last measured HbA1c values were recorded and fingertip fasting blood glucose was measured.

Conditions

Type 2 Diabetes Mellitus and the Effect of Sleep Hygiene Education on Sleep Quality and Glycemic Control

Keywords

Type 2 Diabetes Mellitus; Sleep Hygiene Education; Sleep Quality; Glycemic Control

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)

  Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The primary endpoint is the change in PSQI total score from baseline to post-intervention (end of follow-up), with lower scores indicating better sleep quality.

  3 Months

Secondary Outcomes (1)

• Change in Glycemic Control (HbA1c)

  3 Months

Study Arms (2)

Control Usual Care

NO INTERVENTION

Participants in the control arm receive usual care without any structured sleep hygiene education intervention. They continue their routine diabetes management and follow-up as provided in standard clinical practice. No additional behavioral or educational intervention related to sleep is administered during the study period.

İntervention

EXPERIMENTAL

Participants in this arm receive a structured sleep hygiene education program in addition to usual diabetes care. The education includes guidance on sleep-wake routines, sleep environment optimization, caffeine and screen use reduction, and behavioral strategies to improve sleep quality. The intervention is delivered through standardized educational sessions and written materials

Behavioral: Sleep Hygiene Education

Interventions

Sleep Hygiene Education BEHAVIORAL

Participants in this arm receive a structured sleep hygiene education program in addition to usual diabetes care. The education includes guidance on sleep-wake routines, sleep environment optimization, caffeine and screen use reduction, and behavioral strategies to improve sleep quality. The intervention is delivered through standardized educational sessions and written materials.

İntervention

Eligibility Criteria

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

You may qualify if:

• Diagnosed with type 2 diabetes mellitus for at least 1 year
• Aged 18-65 years
• Pittsburgh Sleep Quality Index (PSQI) score \> 5

You may not qualify if:

• Use of sedative medications
• Working night shifts
• Receiving pharmacological or non-pharmacological treatment for a diagnosed -sleep disorder
• Dementia or psychiatric disorder due to an organic or general medical condition, or history of psychotic disorder or bipolar disorder
• Pregnancy
• Change in diet or diabetes treatment regimen during the study period

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 16, 2026
• Study Start: November 15, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 25, 2022
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

TU (1)