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Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality (SLEEP-ARTerY)

2026年8月24日 更新者：Unidade Local de Saúde do Alto Ave, EPE

Impact of Sleep on Arterial Function, Psychological and Cognitive Complaints in Hypertensive Patients With Poor Sleep Quality

This prospective, parallel-group randomised controlled trial evaluates whether cognitive-behavioural therapy for insomnia (CBT-I) improves arterial function and psychological and cognitive outcomes in hypertensive patients with poor sleep quality. Adults aged 18-70 with controlled hypertension and poor baseline sleep quality (sleep efficiency <=85%) are randomised 1:1 to CBT-I (four weekly 60-minute sessions) or passive sleep education. The primary outcomes are change from baseline in pulse wave velocity and central arterial pressure at 12 months. Secondary outcomes include blood pressure, depressive symptoms, perceived stress, cognitive complaints, and sleep quality, assessed at baseline, 1, 6, and 12 months.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Background: Poor sleep quality is associated with increased arterial stiffness, depression, and cognitive decline, all of which contribute to cardiovascular risk in hypertensive patients. This trial tests whether improving sleep through CBT-I can attenuate arterial dysfunction and psychological/cognitive burden.

Design: Prospective, single-centre, parallel-group randomised controlled trial with 1:1 allocation, conducted at the Hypertension and Psychiatry Outpatient Clinics of the Unidade Local de Saude Alto Ave (ULSAAVE).

Intervention: CBT-I delivered in four weekly 60-minute sessions (sleep hygiene, stimulus control, relaxation techniques), adapted for participants with mild obstructive sleep apnea or comorbid insomnia and sleep apnea (COMISA).

Comparator: Passive sleep education (informational leaflets plus non-interactive follow-up calls); control participants are offered CBT-I after study completion.

Randomisation and blinding: Computer-generated block randomisation (blocks of 4-6), 1:1 allocation, with allocation concealment via sequentially numbered, opaque, sealed envelopes managed by a third party. Outcome assessors and data analysts are blinded; participants are partially blinded (control presented as an educational intervention).

Sample size: 234 participants (117 per group), accounting for 20% attrition, powered (80%, alpha 0.05) to detect a 0.4 m/s between-group difference in pulse wave velocity at 12 months.

Analysis: Linear mixed-effects models for repeated measures (time as fixed effect, participant as random effect, group as factor), with baseline apnea-hypopnea index included as a covariate.

研究类型

介入性

注册 (估计的)

234

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 葡萄牙
    • Braga District
      • Guimarães、Braga District、葡萄牙、4835-044
        • 招聘中
        • Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira
        • 接触：
        • 接触：
        • 首席研究员：
          • Sofia Gomes
        • 副研究员：
          • Ana Daniela Ferreira

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged 18 to 70 years
  • Controlled hypertension
  • Poor baseline sleep quality (sleep efficiency <=85% assessed via actigraphy or type II polysomnography)
  • Capable of providing informed consent
  • Participants with mild obstructive sleep apnea (apnea-hypopnea index 5-14.9/h on type II polysomnography) who do not meet criteria for CPAP/PAP therapy are eligible

Exclusion Criteria:

  • Severe cardiovascular disease (e.g., acute myocardial infarction or stroke)
  • Severe neurological diseases
  • Moderate-to-severe obstructive sleep apnea (AHI >=15/h) or any obstructive sleep apnea with an indication for CPAP/PAP therapy
  • Central disorders of hypersomnolence
  • Intellectual disability
  • Pregnancy

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：CBT-I
Cognitive-behavioural therapy for insomnia: four weekly 60-minute sessions covering sleep hygiene, stimulus control, and relaxation techniques, adapted for participants with mild obstructive sleep apnea or COMISA.
行为的：Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I)
Cognitive-behavioural therapy for insomnia delivered in four weekly 60-minute sessions, incorporating sleep hygiene, stimulus control, and relaxation techniques. Based on baseline polysomnography, the protocol is adapted for participants without obstructive sleep apnea, with mild obstructive sleep apnea, or with comorbid insomnia and mild sleep apnea (COMISA).
有源比较器：Passive sleep education
Informational leaflets plus non-interactive follow-up calls. Control participants are offered CBT-I after study completion.
行为的：Passive sleep education
Passive sleep education consisting of informational leaflets plus non-interactive follow-up calls. Participants in this control condition are offered access to CBT-I after study completion.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change from baseline in pulse wave velocity (PWV)
大体时间：Baseline, 1 month, 6 months, and 12 months
Change from baseline in carotid-femoral pulse wave velocity (m/s), a marker of arterial stiffness.
Baseline, 1 month, 6 months, and 12 months
Change from baseline in central arterial pressure (CAP)
大体时间：Baseline, 1 month, 6 months, and 12 months
Change from baseline in central arterial pressure (mmHg).
Baseline, 1 month, 6 months, and 12 months

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in blood pressure
大体时间：Baseline, 1 month, 6 months, and 12 months
Change from baseline in systolic and diastolic blood pressure (mmHg)
Baseline, 1 month, 6 months, and 12 months
Change from baseline in body weight
大体时间：Baseline, 1 month, 6 months, and 12 months
Change from baseline in body weight (kg).
Baseline, 1 month, 6 months, and 12 months
Change from baseline in body mass index (BMI)
大体时间：Baseline, 1 month, 6 months, and 12 months
Change from baseline in body mass index (kg/m^2).
Baseline, 1 month, 6 months, and 12 months
Change from baseline in depressive symptoms (MADRS)
大体时间：Baseline, 1 month, 6 months, and 12 months
Change from baseline in depressive symptoms measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Scores range from 0 to 60, with higher scores indicating more severe depression.
Baseline, 1 month, 6 months, and 12 months
Change from baseline in depressive symptoms (PHQ-9)
大体时间：Baseline, 1 month, 6 months, and 12 months
Change from baseline in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with higher scores indicating more severe depression.
Baseline, 1 month, 6 months, and 12 months
Change from baseline in perceived stress (PSS)
大体时间：Baseline, 1 month, 6 months, and 12 months
Change from baseline in perceived stress measured by the Perceived Stress Scale (PSS). Higher scores indicate greater perceived stress.
Baseline, 1 month, 6 months, and 12 months
Change from baseline in cognitive function (MoCA)
大体时间：Baseline, 1 month, 6 months, and 12 months
Change from baseline in cognitive function measured by the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with lower scores indicating greater cognitive impairment.
Baseline, 1 month, 6 months, and 12 months
Change from baseline in sleep quality (PSQI)
大体时间：Baseline, 1 month, 6 months, and 12 months
Change from baseline in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21, with higher scores indicating worse sleep quality.
Baseline, 1 month, 6 months, and 12 months
Change from baseline in sleep efficiency
大体时间：Baseline, 1 month, 6 months, and 12 months
Change from baseline in sleep efficiency (%) assessed via actigraphy or type II polysomnography.
Baseline, 1 month, 6 months, and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Unidade Local de Saúde do Alto Ave, EPE

调查人员

  • 首席研究员：Sofia Gomes, MD、Unidade Local de Saúde do Alto Ave
  • 研究主任：Pedro Cunha, PhD、Unidade Local de Saúde do Alto Ave

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月18日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2030年3月1日

研究注册日期

首次提交

2026年8月24日

首先提交符合 QC 标准的

2026年8月24日

首次发布 (实际的)

2026年8月27日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CIC20260049 - CAIDIS (其他标识符：ULSAAVE Ethics Committee)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

A data-sharing plan has not yet been established. Decisions regarding whether and how individual participant data will be shared will be made by the sponsor and investigators, in accordance with institutional policies, ethics committee requirements, and applicable data protection regulations (GDPR). The record will be updated once a decision has been made.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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