Sleep Hygiene Education in Type 2 Diabetes

NCT ID: NCT07347964

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2022-02-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Sleep Hygiene Education

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Oğulcan Çöme

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021/18-18

Identifier Type: -

Identifier Source: org_study_id