Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUnidade Local de Saúde do Alto Ave, EPE
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I)
BehavioralCognitive-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).
Passive sleep education
BehavioralPassive 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.
Treatment groups
234 Participants
are divided into 2 treatment groupsGroup A: CBT-IExperimental treatment 1 intervention
Group B: Passive sleep educationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in pulse wave velocity (PWV)
Change from baseline in carotid-femoral pulse wave velocity (m/s), a marker of arterial stiffness.
Time frame
Baseline, 1 month, 6 months, and 12 months2
Change from baseline in central arterial pressure (CAP)
Change from baseline in central arterial pressure (mmHg).
Time frame
Baseline, 1 month, 6 months, and 12 monthsSecondary outcomes
1
Change from baseline in blood pressure
Change from baseline in systolic and diastolic blood pressure (mmHg)
Time frame
Baseline, 1 month, 6 months, and 12 months2
Change from baseline in body weight
Change from baseline in body weight (kg).
Time frame
Baseline, 1 month, 6 months, and 12 months3
Change from baseline in body mass index (BMI)
Change from baseline in body mass index (kg/m\^2).
Time frame
Baseline, 1 month, 6 months, and 12 months4
Change from baseline in depressive symptoms (MADRS)
Change from baseline in depressive symptoms measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Scores range from 0 to 60, with higher scores indicating more severe depression.
Time frame
Baseline, 1 month, 6 months, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov