Type 2 Diabetes Mellitus and the Effect of Sleep Hygiene Education on Sleep Quality and Glycemic ControlNCT07347964
Sleep Hygiene Education in Type 2 Diabetes
A study testing Sleep Hygiene Education in people with Type 2 Diabetes Mellitus and the Effect of Sleep Hygiene Education on Sleep Quality and Glycemic Control, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus and the Effect of Sleep Hygiene Education on Sleep Quality and Glycemic Control
- What is being tested?
- Sleep Hygiene Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 25 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes mellitus for at least 1 year
- Aged 18-65 years
- Pittsburgh Sleep Quality Index (PSQI) score > 5
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Sleep Hygiene Education
- Keywords
- Type 2 Diabetes Mellitus, Sleep Hygiene Education, Sleep Quality, Glycemic Control
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Sleep Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Secondary outcomes (1)
Change in Glycemic Control (HbA1c)
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).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start15 Nov 2021
- Primary completion15 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus and the Effect of Sleep Hygiene Education on Sleep Quality and Glycemic ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oğulcan Çöme, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347964
- Sponsor's protocol ID
- 2021/18-18
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Hygiene Education on Sleep Quality and Glycemic Control in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07347964
- Acronym / sponsor ID
- 2021/18-18
- Keywords
- Type 2 Diabetes Mellitus, Sleep Hygiene Education, Sleep Quality, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Sleep Hygiene EducationParticipants 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with type 2 diabetes mellitus for at least 1 year
- Aged 18-65 years
- Pittsburgh Sleep Quality Index (PSQI) score > 5
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Hygiene EducationParticipants 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. | Behavioural | İntervention |
Primary outcome
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.
1 secondary outcome
Change in Glycemic Control (HbA1c)
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Hygiene Education in people with Type 2 Diabetes Mellitus and the Effect of Sleep Hygiene Education on Sleep Quality and Glycemic Control, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.