NCT Number: NCT07789535
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Guimarães, Braga District, 4835-044, Portugal
Location status: Recruiting
Ana Daniela Ferreira
SUB_INVESTIGATOR
Pedro Cunha, PhD
CONTACT
Sofia Gomes
PRINCIPAL_INVESTIGATOR
Sofia Gomes, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 1 month, 6 months, and 12 months
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 (mmHg).
Time frame: Baseline, 1 month, 6 months, and 12 months
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 (kg).
Time frame: Baseline, 1 month, 6 months, and 12 months
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 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 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 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 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 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 (%) assessed via actigraphy or type II polysomnography.
Contact information is provided by the study sponsor or research team.
Unidade Local de Saúde do Alto Ave, EPE
Other
Impact of Sleep on Arterial Function, Psychological and Cognitive Complaints in Hypertensive Patients With Poor Sleep Quality
Acronym: SLEEP-ARTerY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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