Sleep Clinical Trial - Sleep & Wellbeing Study

Status Completed

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03012685
Study type	Observational
Source	University of Oxford
Contact
Status	Completed
Phase
Start date	November 2016
Completion date	April 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sleep and Wellbeing Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms