Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality (SLEEP-ARTerY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Insomnia; Arterial Stiffness; Poor Sleep Quality
• Intervention / Treatment: Behavioral: Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I); Behavioral: Passive sleep education

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.

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofia Gomes, MD; Phone Number: + 351 253540330; Email: 3603@ulsaave.min-saude.pt

Study Locations

• Portugal
  • Braga District
    • Guimarães, Braga District, Portugal, 4835-044
      • Recruiting
      • Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira
      • Contact: Sofia Gomes, MD; Phone Number: +351 253 540 330; Email: 3603@ulsaave.min-saude.pt
      • Contact: Pedro Cunha, PhD; Phone Number: +351 253 540 330; Email: pedrocunha@ulsaave.min-saude.pt
      • Principal Investigator: Sofia Gomes
      • Sub-Investigator: Ana Daniela Ferreira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT-I; 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); 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).
Active Comparator: Passive sleep education; Informational leaflets plus non-interactive follow-up calls. Control participants are offered CBT-I after study completion.	Behavioral: Passive 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pulse wave velocity (PWV)	Change from baseline in carotid-femoral pulse wave velocity (m/s), a marker of arterial stiffness.	Baseline, 1 month, 6 months, and 12 months
Change from baseline in central arterial pressure (CAP)	Change from baseline in central arterial pressure (mmHg).	Baseline, 1 month, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in blood pressure	Change from baseline in systolic and diastolic blood pressure (mmHg)	Baseline, 1 month, 6 months, and 12 months
Change from baseline in body weight	Change from baseline in body weight (kg).	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).	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.	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.	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.	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.	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.	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.	Baseline, 1 month, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Unidade Local de Saúde do Alto Ave, EPE
• Investigators: Principal Investigator: Sofia Gomes, MD, Unidade Local de Saúde do Alto Ave; Study Director: Pedro Cunha, PhD, Unidade Local de Saúde do Alto Ave

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: depression; cognitive function; hypertension; pulse wave velocity; sleep quality; arterial stiffness; CBT-I; central arterial pressure
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Hypertension; Depression; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: CIC20260049 - CAIDIS (Other Identifier: ULSAAVE Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No