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Sleep and Arterial Function 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…

ClinicalTrials.gov IDNCT07789535
PhaseNA
Enrollment234
SponsorUnidade Local de Saúde do Alto Ave, EPE
Age18 Years
SexALL
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Conditions studied

Hypertension, Poor Sleep Quality, Insomnia, Arterial Stiffness

About this study

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.

Interventions

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.