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
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.
Exclusion Criteria:
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.
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