Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

Sponsor
Unidade Local de Saúde do Alto Ave, EPE
Study ID
NCT07789535
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I) — BEHAVIORAL
    Cognitive-behavioural therapy for insomnia delivered in four weekly 60-minute sessions, incorporating sleep hygiene, stimulus control, and relaxation techniques. Based on baseline polysomnography, the protocol is adapted for participants without obstructive sleep apnea, with mild obstructive sleep apnea, or with comorbid insomnia and mild sleep apnea (COMISA).
  • Passive sleep education — BEHAVIORAL
    Passive sleep education consisting of informational leaflets plus non-interactive follow-up calls. Participants in this control condition are offered access to CBT-I after study completion.

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
May 18, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
234 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change from baseline in pulse wave velocity (PWV) [ Time Frame: Baseline, 1 month, 6 months, and 12 months ]

Central Contacts

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