Essential HypertensionNCT07257237
Sleep Hygiene Education and Blood Pressure Control in Essential Hypertension in Primary Care
A study testing Sleep hygiene education program in people with Essential Hypertension and Sleep Quality, run by Ozturk Gurer Tutu, MD at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Essential Hypertension, Sleep Quality, Primary Care
- What is being tested?
- Sleep hygiene education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 31 Jul 2024
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 30-65 years
- Physician-diagnosed essential hypertension (office blood pressure >140/90 mmHg or on antihypertensive treatment)
- Under regular follow-up at the family practice center
- At least high school education
- Able and willing to provide written informed consent
Who cannot join
- Impaired mental capacity or cognitive impairment
- Alcohol or substance dependence
- Pregnancy
- Any change in antihypertensive medication within the previous 2 months
- Active infection or active malignancy
- Diagnosed obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dörtyol Özerli Family Health Center
Antakya, Hatay, 31600
About this study
Official title: The Effect of Sleep Hygiene Education on Sleep Quality and Blood Pressure in Patients With Essential Hypertension in a Family Practice Center: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Essential Hypertension, Sleep Quality, Primary Care
- Being tested
- Sleep hygiene education program
- Keywords
- hypertension, sleep hygiene, sleep quality, primary care, Pittsburgh Sleep Quality Index, blood pressure, family medicine, behavioral intervention, randomized controlled trial
- Medical subject headings
- Essential Hypertension, Sleep Initiation and Maintenance Disorders, Hypertension, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep hygiene education programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep hygiene education | Experimental | 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. Receives: Behavioral: Sleep hygiene education program |
| Usual care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 8 weeks after randomization
Secondary outcomes (2)
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.
Measured: 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.
Measured: From baseline to 8 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jan 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies 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
- Model description
- Two-arm, parallel-group randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ozturk Gurer Tutu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ozturk Gurer Tutu, MD, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257237
- Sponsor's protocol ID
- MKU-SLEEPHTN-2024
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Tutu OG, Bilen V, Ozer C. The effect of sleep hygiene education on sleep quality and blood pressure in patients with essential hypertension in a family practice center: a randomized controlled trial. Fam Pract. 2025 Dec 9;43(1):cmaf110. doi: 10.1093/fampra/cmaf110.
PubMed 41511014
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. 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 Blood Pressure in Patients With Essential Hypertension in a Family Practice Center: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07257237
- Acronym / sponsor ID
- MKU-SLEEPHTN-2024
- Conditions
- Essential Hypertension, Sleep Quality, Primary Care
- Keywords
- hypertension, sleep hygiene, sleep quality, primary care, Pittsburgh Sleep Quality Index, blood pressure, family medicine, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Ozturk Gurer Tutu, MDUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 2 Dec 2025 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Sleep hygiene education | Experimental | Behavioral: Sleep hygiene education programParticipants 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. |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 30-65 years
- Physician-diagnosed essential hypertension (office blood pressure >140/90 mmHg or on antihypertensive treatment)
- Under regular follow-up at the family practice center
- At least high school education
- Able and willing to provide written informed consent
Key exclusion criteria (6 listed)
- Impaired mental capacity or cognitive impairment
- Alcohol or substance dependence
- Pregnancy
- Any change in antihypertensive medication within the previous 2 months
- Active infection or active malignancy
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 education programBrief 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. | Behavioural | Sleep hygiene education |
Primary outcome
Change in Pittsburgh Sleep Quality Index (PSQI) global score
Time frame: From baseline to 8 weeks after randomization
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.
2 secondary outcomes
Change in systolic blood pressure (SBP)
Time frame: From baseline to 8 weeks after randomization
Change in diastolic blood pressure (DBP)
Time frame: From baseline to 8 weeks after randomization
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 8 Dec 2025.
- Derived from this study: PubMed 41511014Tutu OG, Bilen V, Ozer C. The effect of sleep hygiene education on sleep quality and blood pressure in patients with essential hypertension in a family practice center: a randomized controlled trial. Fam Pract. 2025 Dec 9;43(1):cmaf110. doi: 10.1093/fampra/cmaf110.
- Zenodo repository: deidentified individual participant data for this trialLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
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 program in people with Essential Hypertension and Sleep Quality, run by Ozturk Gurer Tutu, MD 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 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 8 Dec 2025. 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 Pittsburgh Sleep Quality Index (PSQI) global score (time frame: From baseline to 8 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07257237, which also lists 1 linked publication.
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 8 Dec 2025.