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Fixing insomnia may ease strain on arteries in hypertension

NCT ID NCT07789535

Disease control Sponsor: Unidade Local de Saúde do Alto Ave, EPE Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether cognitive-behavioural therapy for insomnia (CBT-I) can improve arterial function and mental well-being in adults with high blood pressure and poor sleep. Participants aged 18 to 70 with controlled hypertension and poor sleep quality are randomly assigned to either four weekly CBT-I sessions or passive sleep education. Researchers measure changes in arterial stiffness and central blood pressure over 12 months, along with mood, stress, and cognitive complaints.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive-behavioural therapy for insomnia (CBT-I)
What this could lead to
If CBT-I improves arterial stiffness and blood pressure, it could become a non-drug way to lower heart risk in people with hypertension and poor sleep.
What could go wrong
The trial is early and the effect on arteries may be small. CBT-I requires commitment, and results may not apply to everyone with hypertension.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 234 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Depression hypertensive disorder insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arterial stiffness Hypertension Insomnia Poor sleep quality

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira

    RECRUITING

    Guimarães, Braga District, 4835-044, Portugal

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