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Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

RecruitingNAAges 18 Years - 70 YearsAllUnidade Local de Saúde do Alto Ave, EPE
NCT07789535 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I)
  • Passive sleep education
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Where

1 site
Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira
Guimarães, Portugal
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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