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Impact of Sleep on Arterial Function, Psychological and Cognitive Complaints in Hypertensive Patients With Poor Sleep Quality

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Portugal
Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira
RECRUITING
Guimarães
Contact Information
Primary
Sofia Gomes, MD
3603@ulsaave.min-saude.pt
+ 351 253540330
Time Frame
Start Date: 2026-05-18
Estimated Completion Date: 2030-03
Participants
Target number of participants: 234
Treatments
Experimental: CBT-I
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.
Active_comparator: Passive sleep education
Informational leaflets plus non-interactive follow-up calls. Control participants are offered CBT-I after study completion.
Related Therapeutic Areas
Sponsors
Leads: Unidade Local de Saúde do Alto Ave, EPE

This content was sourced from clinicaltrials.gov