An interventional study of Sleep hygiene education program in Essential Hypertension, Sleep Quality and Primary Care, sponsored by Ozturk Gurer Tutu, MD. Completed at 1 site in Turkey (Türkiye). Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Ozturk Gurer Tutu, MD · Not applicable, Interventional, and Treatment
Among 21 studies in Essential Hypertension with a site in Turkey — 6 open to participants now, 6 under way, none of them phase 3. Essential Hypertension · Turkey.
Among the 21 studies in Essential Hypertension with a site in Turkey, this one is the 9th largest by enrollment of the 19 interventional ones that give a count, is one of 4 that started in 2024, is one of 11 with no phase, and was the 19th registered.
478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.
Browse Essential Hypertension studies →6 of the 21 studies in Essential Hypertension with a site in Turkey are open now. Recruiting first, the newest first:
Abant Izzet Baysal University · Sites in Turkey
Yelda Kasımoğlu · Sites in Turkey
Ardahan University · Sites in Turkey
Inonu University · Sites in Turkey
Eskisehir Osmangazi University · Sites in Turkey
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 43 Essential Hypertension studies recruiting now, 15 (35%) set no upper age limit and 20 (47%) stop at 75 or younger; 4 take children under 18; 11 take healthy volunteers.
This study: 30 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2024.
This study's enrollment of 138 is close to the median of 144 across 406 interventional studies indexed under Essential Hypertension.
Median enrollment 130 across the 19 interventional studies, 93 across the 2 observational. Of the 14 that completed or were terminated, 7 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 21 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Ozturk Gurer Tutu, MD as lead sponsor.
Ozturk Gurer Tutu, MD has 1 study filed under Essential Hypertension — fewer than ten, so there is no comparison to draw.
1 of the studies in Essential Hypertension with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07577973Abant Izzet Baysal UniversityThe Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension | 2026-12-01 |
Among the 21 studies in Essential Hypertension with a site in Turkey, from their registry updates:
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This randomized controlled trial evaluated the effect of a brief sleep hygiene education program on sleep quality and blood pressure in adults with essential hypertension attending a family practice center in southern Türkiye. Poor sleep quality is common in patients with hypertension and may contribute to inadequate blood pressure control and increased cardiovascular risk.
In this single-centre trial, 138 adult patients with physician-diagnosed essential hypertension were randomly assigned to an intervention group or a control group. The intervention group received a 10-15 minute face-to-face sleep hygiene education session delivered by a family physician, together with a printed brochure summarising key sleep hygiene recommendations. Participants were asked to keep a sleep diary for 8 weeks and were contacted by telephone at weeks 2, 4, and 6 to reinforce the recommendations. The control group received usual medical care for hypertension without additional education or follow-up contacts.
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), and office blood pressure was measured at baseline and after 8 weeks in both groups. The primary objective was to determine whether sleep hygiene education improves sleep quality; secondary objectives were to evaluate the effects of the intervention on systolic and diastolic blood pressure compared with usual care.
Hypertensive patients frequently report poor sleep quality, which may adversely affect blood pressure control and increase cardiovascular risk. Although pharmacological treatment is the cornerstone of hypertension management, simple behavioural interventions such as sleep hygiene education may provide additional benefits in primary care. This single-centre, parallel-group, randomized controlled trial was conducted in a family practice center in southern Türkiye to investigate whether a structured sleep hygiene education program could improve sleep quality and blood pressure among adults with essential hypertension.
Eligible participants were men and women aged 30-65 years with physician-diagnosed essential hypertension who were under regular follow-up at the family practice center. Patients with impaired cognitive function, alcohol or substance dependence, pregnancy, recent changes in antihypertensive medication, active infection or malignancy, or diagnosed obstructive sleep apnea were excluded. After obtaining written informed consent and completing baseline assessments, participants were randomized in blocks of four to an intervention or control group.
The intervention consisted of a 10-15 minute face-to-face education session on sleep hygiene principles (such as regular sleep-wake schedule, limiting caffeine and screen exposure before bedtime, creating a quiet and dark sleep environment) delivered by a family physician. Participants received a printed brochure summarising these recommendations and were asked to keep a daily sleep diary for 8 weeks. The family physician telephoned participants in the intervention group at weeks 2, 4, and 6 to answer questions and reinforce adherence to sleep hygiene behaviours. The control group received usual care for hypertension without additional contact related to sleep hygiene. No changes to antihypertensive medication were made as part of the study protocol.
The primary outcome was change in Pittsburgh Sleep Quality Index (PSQI) global score from baseline to 8 weeks. Secondary outcomes were changes in systolic and diastolic office blood pressure over the same period. Blood pressure was measured using an automated oscillometric device following a standardised protocol, and the mean of three readings taken after 5 minutes of rest was recorded. The study was approved by the Hatay Mustafa Kemal University Clinical Research Ethics Committee, and all participants provided written informed consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm received a 10-15 minute face-to-face sleep hygiene education session delivered by a family physician during the baseline visit. They were given a printed brochure summarising sleep hygiene recommendations and were asked to keep a sleep diary for 8 weeks. The family physician telephoned participants at weeks 2, 4, and 6 to reinforce adherence to sleep hygiene behaviours.
Behavioral: Sleep hygiene education program
Participants in this arm received usual medical care for essential hypertension according to routine practice in the family practice center. No additional sleep hygiene education, sleep diary, or telephone follow-up related to sleep was provided during the 8-week study period.
Brief structured education on sleep hygiene principles (regular sleep-wake schedule, limiting caffeine and screen exposure before bedtime, creating a quiet and dark sleep environment), delivered face-to-face by a family physician during the baseline visit, supported by a printed brochure and telephone reinforcement at weeks 2, 4, and 6.
Change in Pittsburgh Sleep Quality Index (PSQI) global score
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire assessing sleep quality over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The primary outcome is the change in PSQI global score from baseline to 8 weeks in each group and the difference in mean change between groups.
Time frame: From baseline to 8 weeks after randomization
Change in systolic blood pressure (SBP)
Office systolic blood pressure (mmHg) measured using an automated oscillometric device following a standardised protocol. Three measurements were taken after 5 minutes of rest, and the mean of the three readings was recorded. The outcome is the change in systolic blood pressure from baseline to 8 weeks and the difference in mean change between groups.
Time frame: From baseline to 8 weeks after randomization
Change in diastolic blood pressure (DBP)
Office diastolic blood pressure (mmHg) measured using the same protocol as for systolic blood pressure (three readings after 5 minutes of rest, mean value recorded). The outcome is the change in diastolic blood pressure from baseline to 8 weeks and the difference in mean change between groups.
Time frame: From baseline to 8 weeks after randomization
Plan to share: Yes — Deidentified individual participant data (IPD) for all study variables used in the analyses are publicly available in the Zenodo repository. The dataset includes anonymised sociodemographic characteristics, baseline and follow-up PSQI scores, and systolic and diastolic blood pressure measurements for all participants.
Time frame: The deidentified individual participant data (IPD) and associated data dictionary have been available in the Zenodo repository since 28 July 2025 and will remain publicly accessible for an indefinite period.
Access criteria: Deidentified IPD and the accompanying data dictionary are openly available to any researcher. Data can be downloaded directly from the Zenodo repository without registration, prior approval, or a data use agreement.
Data sharing details ↗ · doi.org
Ran from Jan 2024 to primary completion in Jul 2024, 6 months.
Of 70 non-industry interventional studies with no phase under Essential Hypertension, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 47. This study's 6 months is below that.
Counting every sponsor, half of 80 studies reached it within 20 months; a quarter within 8 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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