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临床试验/NCT07257237
NCT07257237已完成不适用

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

Ozturk Gurer Tutu, MD1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
138
试验地点
1
主要终点
Change in Pittsburgh Sleep Quality Index (PSQI) global score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in Pittsburgh Sleep Quality Index (PSQI) global score

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Ozturk Gurer Tutu, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ozturk Gurer Tutu, MD

Family Medicine Specialist

Mustafa Kemal University

研究点 (1)

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