Diabetic PolyneuropathyNCT07646743
The Effect of Sleep Hygiene Education on Sleep Quality and Quality of Life in Patients With Painful Diabetic Polyneuropathy
A study testing sleep hygiene education in people with Diabetic Polyneuropathy and Sleep Hygiene, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study was designed to the effect of sleep hygiene education on sleep quality and quality of life in patients with painful diabetic polyneuropathy The study was conducted between January 2025 and January 2026 with 24 patients diagnosed with painful diabetic polyneuropathy (12 experimental, 12… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Polyneuropathy, Sleep Hygiene, Pain
- What is being tested?
- sleep hygiene education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2025to 1 Feb 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with type 2 diabetes
- Patients confirmed diagnosis of diabetic polyneuropathy
- Patients not having any other illness besides diabetic polyneuropathy
- Patients not receiving treatment for diabetic polyneuropathy
- Patients with Multiple Sclerosis who volunteer to participate in the study
Who cannot join
- Patients diagnosed with Type 1 diabetes
- Multiple Sclerosis patients who do not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Medical Research and Application Centre
Merkez, Edirne, 22030
About this study
Official title: Ağrılı Diyabetik Polinöropatili Hastalara Verilen Uyku Hijyeni Eğitiminin Uyku Kalitesi Ve Yaşam Kalitesi Üzerine Etkisi
This randomized controlled study was designed to the effect of sleep hygiene education on sleep quality and quality of life in patients with painful diabetic polyneuropathy The study was conducted between January 2025 and January 2026 with 24 patients diagnosed with painful diabetic polyneuropathy (12 experimental, 12 control) at the Neurology clinic and outpatient clinic of a university hospital in Edirne. Data were collected using the "Patient Information Form" including sociodemographic and disease related characteristics, the Electrophysiological Severity Classification, Pittsburgh Sleep Quality Index (PSQI), Brief Pain Inventory (BPI), and SF-12 Health Survey.
Read the detailed description
Background: Sleep disturbances are common in diabetic polyneuropathy (DPN) and adversely affect physical and psychological well-being. This study aimed to evaluate the effects of sleep hygiene education on sleep quality, pain severity, and quality of life in patients with painful DPN.
Methods: This randomized controlled trial was conducted between January 2025 and January 2026 and enrolled 24 patients with electrophysiologically confirmed painful DPN, randomized equally into intervention (n = 12) and control (n = 12) groups. The intervention group received a standardized sleep hygiene education protocol over three months; the control group continued routine care. Participant blinding was not feasible given the nature of the intervention; statistical analyses were conducted with group codes masked. Outcomes were assessed at baseline (T0), month 1 (T1), and month 3 (T2) using the Pittsburgh Sleep Quality Index (PSQI), Brief Pain Inventory (BPI), and SF-12 Health Survey.
Financial Support: The present study was supported by the Research Fund of Trakya University. Project No: 2025/19
- Conditions
- Diabetic Polyneuropathy, Sleep Hygiene, Pain
- Being tested
- sleep hygiene education, Control
- Keywords
- Diabetic Polyneuropathy, Sleep Hygiene, Pain, Quality of Life, Sleep Quality
- Medical subject headings
- Diabetic Neuropathies, Sleep Hygiene, Pain, 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 educationOther
Participants were provided with an educational booklet, and face-to-face training was conducted by a nurse in a dedicated outpatient clinic room during the initial visit.
ControlOther
Participants in the control group continued with their routine treatment and care; no additional educational intervention was provided during this period.
| Study group | Role | What they receive |
|---|---|---|
| control | Other | In the first interview, participants were informed about the research process. Patient information forms and scales (Pittsburgh Sleep Quality Index (PSQI), Brief Pain Inventory (BPI), and SF-12 Health Survey) that would be used in data collection were explained to the participants. Participants were informed about how often and how these forms and scales would be applied. No intervention was applied to the participants in the control group in the study. Receives: Other: Control |
| sleep hygiene education | Experimental | The participants were informed about the research process during the first meeting. Participants were told that, Participants were told that, if they agreed to participate in the study, Over a three-month period at home, the intervention group followed a standardized sleep hygiene education protocol. Participants were provided with an educational booklet, and face-to-face training was conducted by a nurse in a dedicated outpatient clinic room during the initial visit. Weekly reminder messages were sent to encourage participants to keep following the protocol, and adherence was checked at the 1- and 3-month outpatient visits. Receives: Other: sleep hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of sleep score
Change in the mean scores of the Pittsburgh Sleep Quality Index (PSQI)at the first interview, on the 30th day and on the 90th day
Measured: tree month
Quality of life score
Change in the mean scores of the SF-12 Health Survey at the first interview, on the 30th day and on the 90th day
Measured: three month
Pain inventory score
Change in the mean scores of the Brief Pain Inventory (BPI) at the first interview, on the 30th day and on the 90th day
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start7 Jan 2025
- Primary completion15 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYFER GUNES, Trakya University
- Investigators
- Ayfer Gunes, PhD, RN., Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646743
- Sponsor's protocol ID
- 2025/19
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ağrılı Diyabetik Polinöropatili Hastalara Verilen Uyku Hijyeni Eğitiminin Uyku Kalitesi Ve Yaşam Kalitesi Üzerine Etkisi
- ClinicalTrials.gov ID
- NCT07646743
- Acronym / sponsor ID
- 2025/19
- Conditions
- Diabetic Polyneuropathy, Sleep Hygiene, Pain
- Keywords
- Diabetic Polyneuropathy, Sleep Hygiene, Pain, Quality of Life, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 15 Jun 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.
This randomized controlled study was designed to the effect of sleep hygiene education on sleep quality and quality of life in patients with painful diabetic polyneuropathy The study was conducted between January 2025 and January 2026 with 24 patients diagnosed with painful diabetic polyneuropathy (12 experimental, 12 control) at the Neurology clinic and outpatient clinic of a university hospital in Edirne. Data were collected using the "Patient Information Form" including sociodemographic and disease related characteristics, the Electrophysiological Severity Classification, Pittsburgh Sleep Quality Index (PSQI), Brief Pain Inventory (BPI), and SF-12 Health Survey.
Detailed description
Background: Sleep disturbances are common in diabetic polyneuropathy (DPN) and adversely affect physical and psychological well-being. This study aimed to evaluate the effects of sleep hygiene education on sleep quality, pain severity, and quality of life in patients with painful DPN.
Methods: This randomized controlled trial was conducted between January 2025 and January 2026 and enrolled 24 patients with electrophysiologically confirmed painful DPN, randomized equally into intervention (n = 12) and control (n = 12) groups. The intervention group received a standardized sleep hygiene education protocol over three months; the control group continued routine care. Participant blinding was not feasible given the nature of the intervention; statistical analyses were conducted with group codes masked. Outcomes were assessed at baseline (T0), month 1 (T1), and month 3 (T2) using the Pittsburgh Sleep Quality Index (PSQI), Brief Pain Inventory (BPI), and SF-12 Health Survey.
Financial Support: The present study was supported by the Research Fund of Trakya University. Project No: 2025/19
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Other | Other: ControlIn the first interview, participants were informed about the research process. Patient information forms and scales (Pittsburgh Sleep Quality Index (PSQI), Brief Pain Inventory (BPI), and SF-12 Health Survey) that would be used in data collection were explained to the participants. Participants were informed about how often and how these forms and scales would be applied. No intervention was applied to the participants in the control group in the study. |
| sleep hygiene education | Experimental | Other: sleep hygiene educationThe participants were informed about the research process during the first meeting. Participants were told that, Participants were told that, if they agreed to participate in the study, Over a three-month period at home, the intervention group followed a standardized sleep hygiene education protocol. Participants were provided with an educational booklet, and face-to-face training was conducted by a nurse in a dedicated outpatient clinic room during the initial visit. Weekly reminder messages were sent to encourage participants to keep following the protocol, and adherence was checked at the 1- and 3-month outpatient visits. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with type 2 diabetes
- Patients confirmed diagnosis of diabetic polyneuropathy
- Patients not having any other illness besides diabetic polyneuropathy
- Patients not receiving treatment for diabetic polyneuropathy
- Patients with Multiple Sclerosis who volunteer to participate in the study
Key exclusion criteria (2 listed)
- Patients diagnosed with Type 1 diabetes
- Multiple Sclerosis patients who do not volunteer to participate in the study
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 were provided with an educational booklet, and face-to-face training was conducted by a nurse in a dedicated outpatient clinic room during the initial visit. | Other | sleep hygiene education |
| ControlParticipants in the control group continued with their routine treatment and care; no additional educational intervention was provided during this period. | Other | control |
Primary outcome
Quality of sleep score
Time frame: tree month
Change in the mean scores of the Pittsburgh Sleep Quality Index (PSQI)at the first interview, on the 30th day and on the 90th day
Quality of life score
Time frame: three month
Change in the mean scores of the SF-12 Health Survey at the first interview, on the 30th day and on the 90th day
Pain inventory score
Time frame: three month
Change in the mean scores of the Brief Pain Inventory (BPI) at the first interview, on the 30th day and on the 90th day
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 15 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
Ayfer Gunes, PhD, RN. principal investigator
Trakya University
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 Diabetic Polyneuropathy and Sleep Hygiene, run by Trakya 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 5 inclusion and 2 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 15 Jun 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?
Quality of sleep score (time frame: tree month). The study lists 3 primary outcomes in all. 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 15 Jun 2026.