Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality
Recruiting · NCT07789535 · Interventional (participants receive a specific treatment) · Lead sponsor: Unidade Local de Saúde do Alto Ave, EPE
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira - Guimarães, Braga District, Portugal