Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

24. august 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

234

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Portugal
    • Braga District
      • Guimarães, Braga District, Portugal, 4835-044
        • Rekruttering
        • Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Sofia Gomes
        • Underforsker:
          • Ana Daniela Ferreira

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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).
Aktiv komparator: Passive sleep education
Informational leaflets plus non-interactive follow-up calls. Control participants are offered CBT-I after study completion.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in pulse wave velocity (PWV)
Tidsramme: 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)
Tidsramme: Baseline, 1 month, 6 months, and 12 months
Change from baseline in central arterial pressure (mmHg).
Baseline, 1 month, 6 months, and 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in blood pressure
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Unidade Local de Saúde do Alto Ave, EPE

Efterforskere

  • Ledende efterforsker: Sofia Gomes, MD, Unidade Local de Saúde do Alto Ave
  • Studieleder: Pedro Cunha, PhD, Unidade Local de Saúde do Alto Ave

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. maj 2026

Primær færdiggørelse (Anslået)

1. december 2029

Studieafslutning (Anslået)

1. marts 2030

Datoer for studieregistrering

Først indsendt

24. august 2026

Først indsendt, der opfyldte QC-kriterier

24. august 2026

Først opslået (Faktiske)

27. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIC20260049 - CAIDIS (Anden identifikator: ULSAAVE Ethics Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner