SleepNCT03012685
Sleep and Wellbeing Study
An observational study of Sleep and Intrusive Memories, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Most people will experience a psychologically traumatic event, such as a life-threatening accident, at some point in their life. In the initial days after such an event, it is common to be haunted by intrusive memories: image-based memories of the event that spring to mind unbidden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep, Intrusive Memories, Posttraumatic Stress Disorder
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the John Radcliffe Hospital Emergency Department after a traumatic event.
Who may be able to join
- Aged 18 or over
- Experienced or witnessed a traumatic event (i.e. one in which they were exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence)
- Present to the emergency department on the same day as the traumatic event
- Report memory of the event
- Fluent in written and spoken English
- Alert and orientated, Glasgow Coma Scale score (GCS) = 15
- Willing and able to give informed consent and complete study procedures
Who cannot join
- Loss of consciousness
- Current intoxication
- History of severe mental illness
- Current substance abuse or neurological condition
- Currently suicidal
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Emergency Department, John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Relationship Between Sleep the First Night and Week After Trauma and Subsequent Intrusive Memories: a Prospective Study From the Emergency Department
Most people will experience a psychologically traumatic event, such as a life-threatening accident, at some point in their life. In the initial days after such an event, it is common to be haunted by intrusive memories: image-based memories of the event that spring to mind unbidden. Intrusive memories can be distressing in their own right, but are also a hallmark symptom of post-traumatic stress disorder (PTSD).
Sleep is important for many functions involved in how people perceive, respond to and remember events, including stressful/traumatic events. Studies with patients who have experienced traumatic events indicate that sleep disturbances in the first weeks post-trauma are associated with later PTSD symptoms. However, in a previous study with healthy volunteers exposed to experimental trauma (film footage), those who were sleep-deprived in the first night, compared to those who slept, had fewer intrusive memories in the following week. This raises the question of how sleep in the first night, but also the first week, after real-life trauma is related to subsequent intrusive memories and PTSD symptoms.
Read more
The current study is an observational study of patients recruited from a hospital emergency department after a traumatic event. After completing brief baseline questionnaires in the emergency department, participants will be asked to fill in a daily diary of their sleep and intrusive memories over the following week. Post-traumatic stress symptoms, anxiety and depression will be assessed by post/online at one week and two months. Participants will be telephoned after two months to complete an interview to assess PTSD symptoms and an optional feedback interview.
This clinical study will be the first to assess the relationship between sleep in the first night and week, and intrusive memories and mental wellbeing after real-life trauma. Findings may have implications for developing simple sleep-based preventive treatments after trauma in the future.
- Conditions
- Sleep, Intrusive Memories, Posttraumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily diary of sleep and intrusive memories
Measured: 1 week
Secondary outcomes (4)
Actigraphy - to assess sleep timing and duration
Measured: 1 week
Impact of Event Scale-Revised (total score and subscales scores) - to assess post-trauma distress
Measured: At 1 week and 2 months
Hospital Anxiety and Depression Scale
Measured: At 1 week and 2 months
Clinician-Administered PTSD Scale
Measured: At 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionFeb 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Medical Research Council Cognition and Brain Sciences Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012685
- Sponsor's protocol ID
- 16/EM/0326
- Other IDs
- 195832
- Status last verified
- Jan 2025
- First submitted
- 25 Oct 2016
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: It is planned to make an anonymised database available via the Open Science Framework
Publications
Porcheret K, Iyadurai L, Bonsall MB, Goodwin GM, Beer SA, Darwent M, Holmes EA. Sleep and intrusive memories immediately after a traumatic event in emergency department patients. Sleep. 2020 Aug 12;43(8):zsaa033. doi: 10.1093/sleep/zsaa033.
PubMed 32133531
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Sleep the First Night and Week After Trauma and Subsequent Intrusive Memories: a Prospective Study From the Emergency Department
- ClinicalTrials.gov ID
- NCT03012685
- Acronym / sponsor ID
- 16/EM/0326
- Conditions
- Sleep, Intrusive Memories, Posttraumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Medical Research Council Cognition and Brain Sciences Unit
- Study start
- Nov 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most people will experience a psychologically traumatic event, such as a life-threatening accident, at some point in their life. In the initial days after such an event, it is common to be haunted by intrusive memories: image-based memories of the event that spring to mind unbidden. Intrusive memories can be distressing in their own right, but are also a hallmark symptom of post-traumatic stress disorder (PTSD).
Sleep is important for many functions involved in how people perceive, respond to and remember events, including stressful/traumatic events. Studies with patients who have experienced traumatic events indicate that sleep disturbances in the first weeks post-trauma are associated with later PTSD symptoms. However, in a previous study with healthy volunteers exposed to experimental trauma (film footage), those who were sleep-deprived in the first night, compared to those who slept, had fewer intrusive memories in the following week. This raises the question of how sleep in the first night, but also the first week, after real-life trauma is related to subsequent intrusive memories and PTSD symptoms.
The current study is an observational study of patients recruited from a hospital emergency department after a traumatic event. After completing brief baseline questionnaires in the emergency department, participants will be asked to fill in a daily diary of their sleep and intrusive memories over the following week. Post-traumatic stress symptoms, anxiety and depression will be assessed by post/online at one week and two months. Participants will be telephoned after two months to complete an interview to assess PTSD symptoms and an optional feedback interview.
This clinical study will be the first to assess the relationship between sleep in the first night and week, and intrusive memories and mental wellbeing after real-life trauma. Findings may have implications for developing simple sleep-based preventive treatments after trauma in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the John Radcliffe Hospital Emergency Department after a traumatic event.
Key inclusion criteria (7 listed)
- Aged 18 or over
- Experienced or witnessed a traumatic event (i.e. one in which they were exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence)
- Present to the emergency department on the same day as the traumatic event
- Report memory of the event
- Fluent in written and spoken English
Key exclusion criteria (5 listed)
- Loss of consciousness
- Current intoxication
- History of severe mental illness
- Current substance abuse or neurological condition
- Currently suicidal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily diary of sleep and intrusive memories
Time frame: 1 week
4 secondary outcomes
Actigraphy - to assess sleep timing and duration
Time frame: 1 week
Impact of Event Scale-Revised (total score and subscales scores) - to assess post-trauma distress
Time frame: At 1 week and 2 months
Hospital Anxiety and Depression Scale
Time frame: At 1 week and 2 months
Clinician-Administered PTSD Scale
Time frame: At 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Background: PubMed 32133531Porcheret K, Iyadurai L, Bonsall MB, Goodwin GM, Beer SA, Darwent M, Holmes EA. Sleep and intrusive memories immediately after a traumatic event in emergency department patients. Sleep. 2020 Aug 12;43(8):zsaa033. doi: 10.1093/sleep/zsaa033.
- Individual participant dataSharing planned: Yes. It is planned to make an anonymised database available via the Open Science Framework
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Intrusive Memories, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily diary of sleep and intrusive memories (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03012685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.