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HypertensionSLEEP-ARTerYNCT07789535

Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

A study testing Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I) and Passive sleep education in people with Hypertension and Poor Sleep Quality, run by Unidade Local de Saúde do Alto Ave, EPE at 1 site in Portugal.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hypertension, Poor Sleep Quality, Insomnia
What is being tested?
Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I) and Passive sleep education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
1 sitePortugal
Study dates
18 May 2026to Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sofia Gomes, MD contact

+ 351 253540330

3603@ulsaave.min-saude.pt

Portugal1 site, 1 recruiting

  • Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira

    Guimarães, Braga District, 4835-044

    Sofia Gomes, MD, +351 253 540 330, 3603@ulsaave.min-saude.pt

    Pedro Cunha, PhD, +351 253 540 330, pedrocunha@ulsaave.min-saude.pt

    Recruiting

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

Being tested
Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I), Passive sleep education
Keywords
sleep quality, arterial stiffness, CBT-I, pulse wave velocity, central arterial pressure, hypertension, depression, cognitive function
Medical subject headings
Hypertension, Sleep Initiation and Maintenance Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I)Behavioural

    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 educationBehavioural

    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.

Study groups in NCT07789535
Study groupRoleWhat they receive
CBT-IExperimentalCognitive-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.
Receives: Behavioral: Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I)
Passive sleep educationActive comparatorInformational leaflets plus non-interactive follow-up calls. Control participants are offered CBT-I after study completion.
Receives: Behavioral: Passive sleep education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 1 month, 6 months, and 12 months

  2. Change from baseline in central arterial pressure (CAP)

    Change from baseline in central arterial pressure (mmHg).

    Measured: Baseline, 1 month, 6 months, and 12 months

Secondary outcomes (9)

  1. Change from baseline in blood pressure

    Change from baseline in systolic and diastolic blood pressure (mmHg)

    Measured: Baseline, 1 month, 6 months, and 12 months

  2. Change from baseline in body weight

    Change from baseline in body weight (kg).

    Measured: Baseline, 1 month, 6 months, and 12 months

  3. Change from baseline in body mass index (BMI)

    Change from baseline in body mass index (kg/m^2).

    Measured: Baseline, 1 month, 6 months, and 12 months

  4. 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.

    Measured: Baseline, 1 month, 6 months, and 12 months

  5. 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.

    Measured: Baseline, 1 month, 6 months, and 12 months

  6. 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.

    Measured: Baseline, 1 month, 6 months, and 12 months

  7. 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.

    Measured: Baseline, 1 month, 6 months, and 12 months

  8. 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.

    Measured: Baseline, 1 month, 6 months, and 12 months

  9. Change from baseline in sleep efficiency

    Change from baseline in sleep efficiency (%) assessed via actigraphy or type II polysomnography.

    Measured: Baseline, 1 month, 6 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start18 May 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm, parallel-group randomised controlled trial with 1:1 allocation to CBT-I or passive sleep education.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07789535
Sponsor's protocol ID
CIC20260049 - CAIDIS
Other IDs
CIC20260049 - CAIDIS
Acronym
SLEEP-ARTerY
Status last verified
Aug 2026
First submitted
24 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I) and Passive sleep education in people with Hypertension and Poor Sleep Quality, run by Unidade Local de Saúde do Alto Ave, EPE at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sofia Gomes, MD (+ 351 253540330, 3603@ulsaave.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in pulse wave velocity (PWV) (time frame: Baseline, 1 month, 6 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07789535.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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