An interventional study of Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I) and Passive sleep education in Hypertension, Poor Sleep Quality and Insomnia, sponsored by Unidade Local de Saúde do Alto Ave, EPE. Recruiting at 1 site in Portugal. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Unidade Local de Saúde do Alto Ave, EPE · Not applicable, Interventional, and Treatment
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.
Background: Poor sleep quality is associated with increased arterial stiffness, depression, and cognitive decline, all of which contribute to cardiovascular risk in hypertensive patients. This trial tests whether improving sleep through CBT-I can attenuate arterial dysfunction and psychological/cognitive burden.
Design: Prospective, single-centre, parallel-group randomised controlled trial with 1:1 allocation, conducted at the Hypertension and Psychiatry Outpatient Clinics of the Unidade Local de Saude Alto Ave (ULSAAVE).
Intervention: CBT-I delivered in four weekly 60-minute sessions (sleep hygiene, stimulus control, relaxation techniques), adapted for participants with mild obstructive sleep apnea or comorbid insomnia and sleep apnea (COMISA).
Comparator: Passive sleep education (informational leaflets plus non-interactive follow-up calls); control participants are offered CBT-I after study completion.
Randomisation and blinding: Computer-generated block randomisation (blocks of 4-6), 1:1 allocation, with allocation concealment via sequentially numbered, opaque, sealed envelopes managed by a third party. Outcome assessors and data analysts are blinded; participants are partially blinded (control presented as an educational intervention).
Sample size: 234 participants (117 per group), accounting for 20% attrition, powered (80%, alpha 0.05) to detect a 0.4 m/s between-group difference in pulse wave velocity at 12 months.
Analysis: Linear mixed-effects models for repeated measures (time as fixed effect, participant as random effect, group as factor), with baseline apnea-hypopnea index included as a covariate.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 234 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Unidade Local de Saúde do Alto Ave, EPE is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cognitive-behavioural therapy for insomnia: four weekly 60-minute sessions covering sleep hygiene, stimulus control, and relaxation techniques, adapted for participants with mild obstructive sleep apnea or COMISA.
Behavioral: Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I)
Informational leaflets plus non-interactive follow-up calls. Control participants are offered CBT-I after study completion.
Behavioral: Passive sleep education
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).
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.
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 months
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 months
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 months
Change from baseline in body weight
Change from baseline in body weight (kg).
Time frame: Baseline, 1 month, 6 months, and 12 months
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 months
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 months
Change from baseline in depressive symptoms (PHQ-9)
Change from baseline in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with higher scores indicating more severe depression.
Time frame: Baseline, 1 month, 6 months, and 12 months
Change from baseline in perceived stress (PSS)
Change from baseline in perceived stress measured by the Perceived Stress Scale (PSS). Higher scores indicate greater perceived stress.
Time frame: Baseline, 1 month, 6 months, and 12 months
Change from baseline in cognitive function (MoCA)
Change from baseline in cognitive function measured by the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with lower scores indicating greater cognitive impairment.
Time frame: Baseline, 1 month, 6 months, and 12 months
Change from baseline in sleep quality (PSQI)
Change from baseline in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: Baseline, 1 month, 6 months, and 12 months
Change from baseline in sleep efficiency
Change from baseline in sleep efficiency (%) assessed via actigraphy or type II polysomnography.
Time frame: Baseline, 1 month, 6 months, and 12 months
Plan to share: Undecided — A data-sharing plan has not yet been established. Decisions regarding whether and how individual participant data will be shared will be made by the sponsor and investigators, in accordance with institutional policies, ethics committee requirements, and applicable data protection regulations (GDPR). The record will be updated once a decision has been made.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2029, 43 months after the start.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 43 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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Unidade Local de Saúde do Alto Ave, EPE