Arterial Stiffness, Hypertension, Insomnia, Poor Sleep Quality
Conditions
Keywords
sleep quality, arterial stiffness, CBT-I, pulse wave velocity, central arterial pressure, hypertension, depression, cognitive function
Brief 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.
Detailed description
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.
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.
Sponsors
Unidade Local de Saúde do Alto Ave, EPE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcome assessors and data analysts are blinded to group allocation. Participants are partially blinded, with the control condition presented as an educational intervention. Allocation concealment is ensured through sequentially numbered, opaque, sealed envelopes managed by a third party.
Intervention model description
Two-arm, parallel-group randomised controlled trial with 1:1 allocation to CBT-I or passive sleep education.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Participants with mild obstructive sleep apnea (apnea-hypopnea index 5-14.9/h on type II polysomnography) who do not meet criteria for CPAP/PAP therapy are eligible
Exclusion criteria
* 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 * Intellectual disability * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in central arterial pressure (CAP) | Baseline, 1 month, 6 months, and 12 months | Change from baseline in central arterial pressure (mmHg). |
| Change from baseline in pulse wave velocity (PWV) | Baseline, 1 month, 6 months, and 12 months | Change from baseline in carotid-femoral pulse wave velocity (m/s), a marker of arterial stiffness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in perceived stress (PSS) | 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. |
| Change from baseline in cognitive function (MoCA) | 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. |
| Change from baseline in sleep quality (PSQI) | 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. |
| Change from baseline in sleep efficiency | Baseline, 1 month, 6 months, and 12 months | Change from baseline in sleep efficiency (%) assessed via actigraphy or type II polysomnography. |
| Change from baseline in blood pressure | Baseline, 1 month, 6 months, and 12 months | Change from baseline in systolic and diastolic blood pressure (mmHg) |
| Change from baseline in body weight | Baseline, 1 month, 6 months, and 12 months | Change from baseline in body weight (kg). |
| Change from baseline in depressive symptoms (MADRS) | 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. |
| Change from baseline in body mass index (BMI) | Baseline, 1 month, 6 months, and 12 months | Change from baseline in body mass index (kg/m\^2). |
| Change from baseline in depressive symptoms (PHQ-9) | 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. |
Countries
Portugal
Contacts
CONTACTSofia Gomes, MD
PRINCIPAL_INVESTIGATORSofia Gomes, MD
Unidade Local de Saúde do Alto Ave
STUDY_DIRECTORPedro Cunha, PhD
Unidade Local de Saúde do Alto Ave
Outcome results
None listed