MedTrace Logo

Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

NCT07789535 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2026-08-27

No results posted yet for this study

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

Interventions

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).

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.

Sponsors & Collaborators

  • Unidade Local de Saúde do Alto Ave, EPE

    lead OTHER

Principal Investigators

  • Sofia Gomes, MD · Unidade Local de Saúde do Alto Ave

  • Pedro Cunha, PhD · Unidade Local de Saúde do Alto Ave

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2029-12-31
Completion
2030-03-31

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789535 on ClinicalTrials.gov