Insomnia therapy and artery health in people with high blood pressure
Tests insomnia therapy against sleep education in adults with high blood pressure.
Key facts
- Who runs it
- Unidade Local de Saúde do Alto Ave, EPE
- Where
- Guimarães, PortugalSee the site
- Trial code
- Registry title
- Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality
- Status
- Recruiting
- People taking part
- 234 people, planned
- Started
- 18 May 2026
- Expected to end
- Mar 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I)
- Passive sleep education
- Record updated
- 27 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with controlled high blood pressure and poor sleep. It tests whether a talking therapy for insomnia (CBT-I) improves how the arteries work.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Controlled hypertension (high blood pressure) with poor sleep quality, meaning sleep efficiency of 85% or less measured by actigraphy or type II polysomnography. Mild sleep apnea (apnea-hypopnea index 5-14.9/h) that does not need CPAP/PAP therapy is allowed.
- Biomarker or test result
- Sleep efficiency of 85% or less on actigraphy or type II polysomnography.
Main reasons for not taking part
- Severe cardiovascular disease, such as acute myocardial infarction or stroke
- Severe neurological diseases
- Moderate-to-severe sleep apnea (AHI 15/h or more), or any sleep apnea needing CPAP/PAP therapy
- Central disorders of hypersomnolence
- Intellectual disability or pregnancy
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Moderate-to-severe obstructive sleep apnea (AHI >=15/h) or any obstructive sleep apnea with an indication for CPAP/PAP therapy
- Severe cardiovascular disease (e.g., acute myocardial infarction or stroke)
- Severe neurological diseases
- Central disorders of hypersomnolence
- Intellectual disability
- Pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in Portugal
- Unidade Local de Saúde do Alto Ave - Hospital Senhora da OliveiraGuimarães, PortugalContact: Sofia Gomes, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- CBT-ITreatment being tested
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.
Treatment: Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I)
- Passive sleep educationExisting treatment, for comparison
Informational leaflets plus non-interactive follow-up calls. Control participants are offered CBT-I after study completion.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of Sleep on Arterial Function, Psychological and Cognitive Complaints in Hypertensive Patients With Poor Sleep Quality
- Plain-language title
- Insomnia therapy and artery health in people with high blood pressureGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07789535, who can take part
- Record updated
- 27 August 2026