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Could a simple sleep guide ease insomnia in lung disease?

NCT ID NCT07754981

Symptom relief Sponsor: University of Sheffield Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether a set of self-help booklets, based on cognitive behavioural therapy for insomnia (CBT-I), can improve sleep quality in adults with pulmonary hypertension (PH). Participants will be randomly assigned to receive the booklets during the study or after a waiting period. The programme covers sleep hygiene and strategies to address unhelpful thoughts, with questionnaires measuring sleep and mental wellbeing over several weeks.

What this could mean

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

Active substance
A self-help sleep hygiene intervention based on Cognitive Behavioural Therapy for Insomnia (CBT-I), delivered as four weekly booklets.
What this could lead to
If effective, this low-cost, home-based programme could offer a practical way to improve sleep and wellbeing for people with pulmonary hypertension.
What could go wrong
This is a small pilot study, so results may not be conclusive. The intervention relies on self-report and may not work for everyone.

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 60 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

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 years and older

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: Participants much be aged 18 years and over. Must have a diagnosis of PH, which they will be asked to self-report i.e. we will not ask for proof. Must be able to meet the requirements of the study: give informed consent; complete questionnaires; be literate in English. Must self-report sleep difficulties. This will be asked as a categorical (yes/no) question rather than captured through an outcome measure. No sleep measure has been validated for this population. Whilst we can measure sleep, we are unable to quantify difficulties and cannot use a more standardised method of determining a clinical cut off for when a participant may be included or excluded from the study. Exclusion Criteria: Participants displaying any significant issues of risk such as self-reported thoughts of harm to self or suicidal thoughts will not be eligible for this study. This is because they are unlikely to benefit from a self-help intervention. this will be asked during a screening questionnaire prior to accessing the consent form. Instead, we will signpost this group to relevant services.

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Conditions

The condition(s) this trial relates to.

insomnia pulmonary hypertension Sleep Hygiene

As listed by the trial registrant

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

Insomnia Pulmonary hypertension Sleep hygiene

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

  • Clinical Psychology Unit

    Sheffield, South Yorkshire, S1 4DP, United Kingdom

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