Sleep and arterial function in hypertensive patients with poor sleep quality
Official title: Impact of Sleep on Arterial Function, Psychological and Cognitive Complaints in Hypertensive Patients With Poor Sleep Quality
Run by Unidade Local de Saúde do Alto Ave, EPE · NCT07789535 · Data updated 2026-11-12
This trial tests whether using cognitive-behavioural therapy for insomnia can improve artery health and well-being in adults with high blood pressure and poor sleep.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 234 (estimated) |
| Sponsor | Unidade Local de Saúde do Alto Ave, EPE Academic / other |
| Locations | 1 site (Guimarães, Braga District) |
| Status | Recruiting |
| Started | May 18, 2026 |
| Main results expected | December 2029 |
| Study ends | March 2030 |
| Registry record updated | August 27, 2026 |
| Trial ID | NCT07789535 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-70 with controlled hypertension and poor sleep quality (sleep efficiency ≤85%), including those with mild sleep apnea not requiring CPAP/PAP therapy.
✕Probably not a fit
Individuals with severe cardiovascular disease, moderate-to-severe obstructive sleep apnea needing CPAP/PAP, central sleep disorders, or other major neurological or pregnancy exclusions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-centre randomized trial comparing cognitive-behavioural therapy for insomnia (CBT-I) delivered over four weekly sessions to passive sleep education in adults with controlled hypertension and poor sleep quality. The study measures arterial stiffness and central arterial pressure at 12 months, along with BP, depressive symptoms, stress, cognitive complaints, and sleep quality, with follow-ups at 1, 6, and 12 months. Participants with mild sleep apnea or COMISA are eligible and CBT-I is tailored to accommodate these conditions. Allocation is 1:1, with blinded outcome assessment and data analysis, and participants in the control arm are offered CBT-I after study completion.
Why it matters
Potential benefit: If successful, CBT-I could reduce arterial stiffness and improve mood, stress, and cognitive symptoms in hypertensive patients with poor sleep.
How similar studies have gone: Earlier work suggests sleep improvement can influence vascular function and psychological outcomes, but this exact CBT-I approach in hypertensive patients with poor sleep quality is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira
Guimarães, Braga District, Portugal Recruiting
Study contacts
- Principal investigator: Sofia Gomes, MD — Unidade Local de Saúde do Alto Ave
- Study coordinator: Sofia Gomes, MD
- Email: 3603@ulsaave.min-saude.pt
- Phone: + 351 253540330
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.