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Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

RECRUITINGN/ASponsored by Unidade Local de Saúde do Alto Ave, EPE
Actively Recruiting
PhaseN/A
SponsorUnidade Local de Saúde do Alto Ave, EPE
Started2026-05-18
Est. completion2029-12
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions5

Arterial StiffnessDepressionHypertensionInsomniaPoor Sleep Quality

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