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

24 augustus 2026 bijgewerkt door: Unidade Local de Saúde do Alto Ave, EPE

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

234

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Portugal
    • Braga District
      • Guimarães, Braga District, Portugal, 4835-044
        • Werving
        • Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Sofia Gomes
        • Onderonderzoeker:
          • Ana Daniela Ferreira

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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).
Actieve vergelijker: Passive sleep education
Informational leaflets plus non-interactive follow-up calls. Control participants are offered CBT-I after study completion.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in pulse wave velocity (PWV)
Tijdsspanne: Baseline, 1 month, 6 months, and 12 months
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)
Tijdsspanne: Baseline, 1 month, 6 months, and 12 months
Change from baseline in central arterial pressure (mmHg).
Baseline, 1 month, 6 months, and 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in blood pressure
Tijdsspanne: Baseline, 1 month, 6 months, and 12 months
Change from baseline in systolic and diastolic blood pressure (mmHg)
Baseline, 1 month, 6 months, and 12 months
Change from baseline in body weight
Tijdsspanne: Baseline, 1 month, 6 months, and 12 months
Change from baseline in body weight (kg).
Baseline, 1 month, 6 months, and 12 months
Change from baseline in body mass index (BMI)
Tijdsspanne: Baseline, 1 month, 6 months, and 12 months
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)
Tijdsspanne: 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.
Baseline, 1 month, 6 months, and 12 months
Change from baseline in depressive symptoms (PHQ-9)
Tijdsspanne: 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.
Baseline, 1 month, 6 months, and 12 months
Change from baseline in perceived stress (PSS)
Tijdsspanne: 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.
Baseline, 1 month, 6 months, and 12 months
Change from baseline in cognitive function (MoCA)
Tijdsspanne: 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.
Baseline, 1 month, 6 months, and 12 months
Change from baseline in sleep quality (PSQI)
Tijdsspanne: 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.
Baseline, 1 month, 6 months, and 12 months
Change from baseline in sleep efficiency
Tijdsspanne: Baseline, 1 month, 6 months, and 12 months
Change from baseline in sleep efficiency (%) assessed via actigraphy or type II polysomnography.
Baseline, 1 month, 6 months, and 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Unidade Local de Saúde do Alto Ave, EPE

Onderzoekers

  • Hoofdonderzoeker: Sofia Gomes, MD, Unidade Local de Saúde do Alto Ave
  • Studie directeur: Pedro Cunha, PhD, Unidade Local de Saúde do Alto Ave

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 mei 2026

Primaire voltooiing (Geschat)

1 december 2029

Studie voltooiing (Geschat)

1 maart 2030

Studieregistratiedata

Eerst ingediend

24 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 augustus 2026

Eerst geplaatst (Werkelijk)

27 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

24 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CIC20260049 - CAIDIS (Andere identificatie: ULSAAVE Ethics Committee)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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