An interventional study of Sleep Hygiene Self-Help Intervention in Pulmonary Hypertension, Insomnia and Sleep Hygiene, sponsored by University of Sheffield. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by University of Sheffield · Not applicable, Interventional, and Other
The researchers have developed a set of self-help booklets for adults with pulmonary hypertension (PH) who are experiencing sleep problems. The booklets include sleep hygiene advice and are based on a psychological treatment called Cognitive Behavioural Therapy for Insomnia (CBT-I).
CBT-I is a structured, evidence-based treatment for ongoing sleep problems. It helps people understand how their thoughts, behaviours, and daily routines can affect their sleep. It aims to improve sleep quality and help people fall asleep more easily and get back to sleep if they wake during the night.
CBT-I is one of the most effective treatments for ongoing sleep problems. The self-help programme consists of four booklets, which participants will work through at home over four weeks, completing one booklet each week in their own time. The aim of the study is to find out whether the self-help booklets improve sleep quality in people with pulmonary hypertension.
Participants will be asked to complete questionnaires about their sleep and mental wellbeing, including symptoms of anxiety and depression. Participants will then be randomly allocated to one of two groups. The intervention group will receive the self-help booklets during the study. The wait-list group will receive the booklets at a later date if they are found to be helpful. Having two groups allows the researchers to compare the results and determine whether any improvements in sleep are due to the self-help booklets.
Participants in the intervention group will also be contacted during the programme to ask about their experiences of using the booklets. Both groups will complete the questionnaires again after four weeks and then again one month later. Participants in the intervention group will also be contacted at the end of the study to discuss their experiences of taking part.
Pulmonary hypertension (PH) is an umbrella term used to describe conditions associated with elevated blood pressure in the pulmonary arteries. Approximately 8,000 people live with PH in the UK severe enough to need specialist care. Without this, the disease can lead to right sided heart failure and early mortality. The range of symptoms include breathlessness, fatigue and chest pain and many have to deal with the high burden of treatment and reduced physical activity.
As treatments PH have advanced, survival rates have improved, drawing attention to the burden the disease places on both healthcare systems and individuals. However, despite increased longevity, symptoms remain significant, and most forms of PH are still incurable. Improving health-related quality of life (HRQoL) is therefore a key priority.
Whilst the research exploring sleep and PH is limited, the prevalence and impact that sleep disturbances can have on HRQoL and the ability to cope with symptoms is becoming more recognised. Research has found an association between increasing levels of sleep disturbances and a worsening of PH symptoms, HRQoL and psychological states. This suggests that psychological distress could be one factor explaining sleep disturbances, or at least is a consequence of sleep difficulties. Further research is needed to identify the relationship between sleep disturbances and psychosocial distress, and to test interventions that target sleep. While there is a growing number of trials exploring the usefulness of psychological therapies targeting distress associated with PH, none have specifically examined the impact on sleep.
Currently there are no National Healthcare Service (NHS) commissioned sleep pathways specifically for individuals with PH and no PH specific sleep interventions are recommended by the National Institute for Health and Care Excellent (NICE). Individuals would receive non-disease specific interventions and this is likely to pose a barrier to accessing care. NICE guidelines recommend advice (self-help) about sleep hygiene as a usual treatment, with face-to-face CBT-I recommended as best practice if insomnia symptoms persist.
The primary aim of this study is to develop a self-help sleep hygiene intervention specifically tailored for individuals who have been diagnosed with PH, in order to improve their self-reported sleep quality. This intervention will be created in collaboration with PHA UK, so that both experts by education and experts by experience can contribute to its structure and content. PHA UK, is the leading charity in the UK for people impacted by PH with over 4,500 service users.
The secondary aim of the study is to conduct a pilot randomised controlled trial to explore the acceptability and feasibility of this tailored intervention, through the collection of both quantitative and qualitative data. This will focus on: recruitment; adherence; retention; outcome measure data; participant feedback and any adverse effects and will guide decisions on the feasibility of progressing to a full RCT.
Participants will be into one of two groups at random. One group will receive the self-help intervention within a few days. The other group will receive the intervention once the study is complete, but only if the intervention was found to be helpful. Participants in the intervention group, will be asked to work through the intervention in their own time at home. The intervention includes information about pulmonary hypertension and sleep and how the two can interact. It will also provide them with range of techniques and skills to practice, to help them to get a better night sleep and reduce the worry, low mood and physical symptoms associated with poor sleep and insomnia.
All participants will be required to complete series of measures before and after the intervention and at a one month follow up. This study is a 2 (intervention or control group) x 3 (pre, post, 1-month follow up) mixed factorial design. Due to the nature of the intervention, this study will not involve any blinding of participants to group allocation.
Quantitative Data:
Qualitative Data:
The data gathered from the feedback questionnaires will be analysed using content analysis:
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's planned enrollment of 60 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →University of Sheffield is the lead sponsor of 75 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 ; 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the wait-list control group will not receive the self-help intervention during the study and will be compared with the intervention group on the study outcome measures. If the self-help intervention is found to be helpful, participants in the wait-list control group will be offered the intervention after the study has been completed.
The intervention will be a series of self-help booklets aiming to improve sleep quality. The content and length of the intervention has been finalised in collaboration with PHA-UK to ensure it is also informed by experts by experience and education and the Medical Research Council framework for developing complex interventions (Skivington et al., 2021) will be adhered to.
Behavioral: Sleep Hygiene Self-Help Intervention
Participants randomised to the intervention group will be sent a sleep hygiene self-help intervention for PH. The content of the sessions has been informed by pre-existing self-help booklets, sleep hygiene advice and CBT-I interventions and has been created in collaboration with PHA-UK. The self-help materials will be provided online and will take 4 weeks for the participant to complete at home, with one booklet for each week: WEEK ONE: Sleep difficulties and PH WEEK TWO: How to sleep better WEEK THREE: Working on tricky thoughts WEEK FOUR: Maintaining progress
Pittsburgh Sleep Quality Index (PSQI)
Consists of 19 items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, with higher scores indicating greater dysfunction; these are summed to yield a global score ranging from 0 to 21.
Time frame: Outcome measures will be collected before the intervention (baseline), immediately after the four-week intervention, and at a one-month follow-up (eight weeks from baseline).
Sleep Hygiene Index (SHI)
Consists of 13 items that measure the frequency of behaviours such as consumption of caffeine or alcohol before bedtime, irregular sleep schedules, and engaging in stimulating activities prior to sleep. Respondents rate each item on a five-point Likert scale ranging from 0 (never) to 4 (always), with higher scores indicating poorer sleep hygiene.
Time frame: Outcome measures will be collected before the intervention (baseline), immediately after the four-week intervention, and at a one-month follow-up (eight weeks from baseline).
Generalized Anxiety Disorder 7 (GAD-7)
Assess symptoms of generalized anxiety over the past two weeks. Each of the seven items corresponds to core anxiety symptoms and is rated on a 4-point Likert scale from 0 ("not at all") to 3 ("nearly every day"), yielding a total score ranging from 0 to 21. Scores of 5, 10, and 15 represent cut-off points for mild, moderate, and severe anxiety and it has a reliable change index of 4.
Time frame: Outcome measures will be collected before the intervention (baseline), immediately after the four-week intervention, and at a one-month follow-up (eight weeks from baseline).
The Patient Health Questionnaire-8 (PHQ-8)
It contains eight items, each scored from 0 ("not at all") to 3 ("nearly every day"), generating a total score ranging from 0 to 24. Clinical cut-offs of 5, 10, 15, and 20 correspond to mild, moderate, moderately severe, and severe depression, respectively. Scores below 10 suggest mild symptoms or no significant depression.
Time frame: Outcome measures will be collected before the intervention (baseline), immediately after the four-week intervention, and at a one-month follow-up (eight weeks from baseline).
emPHasis-10
Assess HRQoL in individuals with PH It contains 10 items covering key domains relevant to the lived experience of PH, including breathlessness, fatigue, emotional wellbeing, and social functioning. Each item is rated on a 0-5 Likert scale, with total scores ranging from 0 to 50. Higher scores indicate a lower HRQoL.
Time frame: Outcome measures will be collected before the intervention (baseline), immediately after the four-week intervention, and at a one-month follow-up (eight weeks from baseline).
Dyspnoea-12 (D12)
Assesses the severity and impact of breathlessness, which is a common symptom of PH. The D12 is a validated, 12-item measure that captures both physical and affective components of dyspnoea, with total scores ranging from 0 to 36; higher scores indicate greater symptom burden.
Time frame: Outcome measures will be collected before the intervention (baseline), immediately after the four-week intervention, and at a one-month follow-up (eight weeks from baseline).
Plan to share: No — The participants data will not be shared with any researchers outside of the research team and all participants data will be anonymised in any future publications.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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