NCT07789535Recruiting
Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality
Impact of Sleep on Arterial Function, Psychological and Cognitive Complaints in Hypertensive Patients With Poor Sleep Quality
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 234 (estimated)
- First submitted
- 24 Aug 2026
- Start date
- 18 May 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- Unidade Local de Saúde do Alto Ave, EPE
- Diseases
- High blood pressure
- NCT number
- NCT07789535
What you commit to
- Study type: Interventional
- Planned participants: 234
- From 18 May 2026 to the primary completion date, Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Moderate-to-severe obstructive sleep apnea (AHI \>=15/h) or any obstructive sleep apnea with an indication for CPAP/PAP therapy
Other illness
- Severe cardiovascular disease (e.g., acute myocardial infarction or stroke)
- Severe neurological diseases
- Central disorders of hypersomnolence
Other
- Intellectual disability
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira Coordinator of this site? Confirm its status | Guimarães | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.