RecruitingNot ApplicableNCT07789535

Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

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

Sponsor

Unidade Local de Saúde do Alto Ave, EPE

Enrollment

234 participants

Start Date

May 18, 2026

Study Type

INTERVENTIONAL

Conditions

Arterial Stiffness Insomnia Hypertension Poor sleep quality

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I) and a behavioral approach called Passive sleep education for people with arterial stiffness, hypertension, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBehavioral: 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).

BEHAVIORALPassive 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.