Sleep Hygiene Education and Blood Pressure Control in Essential Hypertension in Primary Care

NCT07257237 | Completed

• 1 other identifier: MKU-SLEEPHTN-2024
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep Quality; Primary Care; Essential Hypertension

Keywords

hypertension; sleep hygiene; sleep quality; primary care; Pittsburgh Sleep Quality Index; blood pressure; family medicine; behavioral intervention; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 8 weeks after randomization

Secondary Outcomes (2)

• Change in systolic blood pressure (SBP)

  From baseline to 8 weeks after randomization

• Change in diastolic blood pressure (DBP)

  From baseline to 8 weeks after randomization

Study Arms (2)

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.

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.

Interventions

Sleep hygiene education program BEHAVIORAL

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.

Sleep hygiene education

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ozturk Gurer Tutu, MD: lead

Study Sites (1)

Dörtyol Özerli Family Health Center

Antakya, Hatay, 31600, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 41511014 DERIVED

Related Links

• Zenodo repository: deidentified individual participant data for this trial

MeSH Terms

Conditions

Essential Hypertension; Sleep Initiation and Maintenance Disorders; Hypertension; Sleep Hygiene

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The trial used an open-label design for participants and family physicians. However, nurses who measured blood pressure as an outcome were blinded to group assignments throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Family Medicine Specialist

Model Details: Two-arm, parallel-group randomized controlled trial.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

TU (1)