Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

NCT07789535 | Recruiting

• 1 other identifier: CIC20260049 - CAIDIS
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Poor Sleep Quality; Insomnia; Arterial Stiffness

Keywords

sleep quality; arterial stiffness; CBT-I; pulse wave velocity; central arterial pressure; hypertension; depression; cognitive function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change from baseline in blood pressure

  Baseline, 1 month, 6 months, and 12 months

• Change from baseline in body weight

  Baseline, 1 month, 6 months, and 12 months

• Change from baseline in body mass index (BMI)

  Baseline, 1 month, 6 months, and 12 months

• Change from baseline in depressive symptoms (MADRS)

  Baseline, 1 month, 6 months, and 12 months

• Change from baseline in depressive symptoms (PHQ-9)

  Baseline, 1 month, 6 months, and 12 months

Study Arms (2)

CBT-I

EXPERIMENTAL

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)

Passive sleep education

ACTIVE COMPARATOR

Informational leaflets plus non-interactive follow-up calls. Control participants are offered CBT-I after study completion.

Behavioral: Passive sleep education

Interventions

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

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).

CBT-I

Passive sleep education BEHAVIORAL

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.

Passive sleep education

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unidade Local de Saúde do Alto Ave, EPE: lead

Study Sites (1)

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

Guimarães, Braga District, 4835-044, Portugal

RECRUITING

MeSH Terms

Conditions

Hypertension; Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Sofia Gomes, MD

  Unidade Local de Saúde do Alto Ave

  PRINCIPAL INVESTIGATOR

• Pedro Cunha, PhD

  Unidade Local de Saúde do Alto Ave

  STUDY DIRECTOR

Central Study Contacts

Sofia Gomes, MD

CONTACT

+ 351 253540330; 3603@ulsaave.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel-group randomised controlled trial with 1:1 allocation to CBT-I or passive sleep education.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

PT (1)