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NCT07789535 · ClinicalTrials.gov record · last posted 2026-08-27

Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

Study acronym: SLEEP-ARTerY
StatusRecruiting
PhaseNot applicable
Started2026-05-18
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from the ClinicalTrials.gov record
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.
Trial Details
NCT Number NCT07789535
Lead Sponsor Unidade Local de Saúde do Alto Ave, EPE
Conditions Hypertension, Poor Sleep Quality, Insomnia, Arterial Stiffness
Enrollment 234 participants
Start Date 2026-05-18
Primary Completion 2029-12 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-27