Sleep Hygiene Education in Type 2 Diabetes

January 11, 2026 updated by: Oğulcan Çöme, Dokuz Eylul University

The Effect of Sleep Hygiene Education on Sleep Quality and Glycemic Control in Patients With Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Usual Care
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.
Experimental: İntervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Time Frame: 3 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycemic Control (HbA1c)
Time Frame: 3 Months
Glycemic control will be assessed using glycated hemoglobin (HbA1c, %). The secondary outcome is the change in HbA1c levels from baseline to post-intervention (end of follow-up).
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

February 25, 2022

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/18-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data will not be shared publicly due to ethical concerns. Data may be made available upon reasonable request, subject to approval by the ethics committee and in accordance with data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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