Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

Condition(s) studied

Investigational drug(s) / intervention(s)

Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I): 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: 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 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

Primary outcome measure(s)

• Change from baseline in pulse wave velocity (PWV) — Baseline, 1 month, 6 months, and 12 months
  Change from baseline in carotid-femoral pulse wave velocity (m/s), a marker of arterial stiffness.
• Change from baseline in central arterial pressure (CAP) — Baseline, 1 month, 6 months, and 12 months
  Change from baseline in central arterial pressure (mmHg).

Trial sites (1)

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