Condition category
Mental and Behavioural Disorders
Date applied
01/04/2020
Date assigned
08/04/2020
Last edited
29/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Stressful life events can cause a short-term disruption to sleep. This can cause people to try and compensate for the sleep disruption. For example, people might then spend too long in bed, or become preoccupied with the daytime consequences of this poor or disturbed sleep. Over time, we know that this can create long-term sleep problem such as insomnia.

Previous research studies have shown that stressful major events, in the form of natural disasters such as earthquakes, can disrupt sleep. The ongoing COVID-19 (coronavirus) pandemic might therefore cause people to develop sleep problems. However, by intervening early, we think that short-term sleep disruption can be stopped. This is likely to prevent short-term sleep disruption from becoming a long-term problem.

The aim of this study is to use an online treatment, in the form of sleep education, to try and treat short-term sleep problems in people who have recently reported having poor sleep, particularly as a result of the ongoing COVID-19 pandemic. This involves being provided with an online version of a leaflet which suggests ways in which people can change their behaviour to avoid poor sleep from becoming a problem. We have previously used a version of this leaflet with people who have long-term sleep problems (insomnia) and it has been effective.

We are also looking for people who do not have sleep problems to take part in this study because we want to understand if this intervention can prevent sleep problems, from happening in the first place. We also need people who do not have sleep problems to take part so that we can measure whether or not the treatment is effective for people who do have sleep problems.

Who can participate?
Adults over 18 years, who are either affected by poor sleep or are good sleepers.

What does the study involve?
This study will be conducted entirely online and participants will not need to visit Northumbria University at any point.

The first part of the study involves completing some questionnaires about sleep habits and sleep quality, stress levels and general mood. Participants will also be asked some questions in relation to the ongoing COVID-19 pandemic, and brief questions about health and employment. This would take approximately 30 to 45 minutes to complete.

The researchers will then ask participants to keep a daily log of their sleep for one week, by completing what is known as a ‘sleep diary’. This takes less than five minutes to complete each day and involves noting down details including what time participants went to sleep, how long participants slept for, and whether participants woke up during the night or not. This will be done using an online link which participants can complete on their computer, tablet, or mobile phone.

The next step of the study will depend on which group participants are in. This study is a type of study called a randomised controlled trial. This means that some participants will receive the treatment, and some people will not receive the treatment.

The treatment is an online version of a leaflet which the researchers have previously used in face-to-face studies with people who have clinical sleep problems. This involves being told about various different practical behaviours which participants can do to help improve sleep. This leaflet has been shown to be effective and the researchers want to see if the online version is also effective, because this will allow us to deliver this very cheaply and reach lots of people at once.

If participants are a poor sleeper, participants will be given details of the treatment and the researchers will ask participants to keep a sleep diary for another week, before repeating some of the questionnaires the researchers asked participants to complete at the start of the study. This will allow us to see if the treatment works, and if the effects change over time.

If participants are a good sleeper, participants will be randomly placed into one of two groups. The first group will receive the treatment, but after a delay of one week. The researchers would ask participants to complete sleep diaries for an extra week. This delay is important because it lets us work out if the treatment is effective for the people who report having poor sleep.

The other group of good sleepers will not receive the treatment and will instead continue to complete sleep diaries for two weeks. Therefore, participation will take two weeks in total for poor sleepers, who will receive the treatment, and good sleepers who do not receive the treatment. Participation will take three weeks in total for good sleepers who do receive the treatment.

The researchers are also interested in tracking the sleep of good sleepers, who do not report having any problems with their sleep, throughout the COVID-19 pandemic as this may help us to develop new behavioural treatments for poor sleep.

What are the possible benefits and risks of participating?
In terms of direct advantages, the potential advantages of taking part in this study are that participants may receive treatment which might help current sleep problems, or which may prevent future sleep problems from developing. If participants do not receive the treatment, participants will not receive any direct advantage but participants will still be helping to improve treatments for sleep problems. There are very unlikely to be any disadvantages of taking part in this study. The researchers have used this treatment in the past, in multiple face-to-face research studies with people who have long-term sleep problems, and there have not been any side effects.

Where is the study run from?
Northumbria Sleep Research Laboratory, Northumbria University (UK)

When is the study starting and how long is it expected to run for?
April 2020 to April 2022

Who is funding the study?
Northumbria University (UK)

Who is the main contact?
Dr Greg Elder
g.elder@northumbria.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Greg Elder

ORCID ID

Contact details

Northumbria Sleep Research Laboratory
Northumbria University
Newcastle upon Tyne
NE1 8ST
United Kingdom
+44 (0)191 227 3241
g.elder@northumbria.ac.uk

Type

Scientific

Additional contact

Dr Greg Elder

ORCID ID

Contact details

Northumbria Sleep Research Laboratory
Northumbria University
Newcastle upon Tyne
NE1 8ST
United Kingdom
+44 (0)191 227 3241
g.elder@northumbria.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic (Sleep COVID-19)

Acronym

Sleep COVID-19

Study hypothesis

The intervention will reduce insomnia severity in poor sleepers relative to good sleepers

Ethics approval

Approved 09/04/2020, Northumbria University (Department of Psychology, Northumbria University, Newcastle-upon-Tyne, UK; no tel. provided; nick.neave@northumbria.co.uk), ref: 23377

Study design

Interventional cluster randomized trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute insomnia

Intervention

This is an interventional study where good sleepers will be recruited as a wait-list control, where they will receive the treatment after a delay of one week. An additional group of good sleeper participants will be recruited who will not receive the intervention. An equal number of participants will be recruited to each group and healthy good sleepers and individuals with sleep problems will be recruited at a 2:1 ratio (estimated n = 40:20 participants).

The study is single-centre and the study will be run entirely online.

Participants who are in the two intervention groups (poor sleep and wait-list control good sleepers) will be provided with an online version of a self-help leaflet. A printed version of this leaflet has been used in previous treatment studies conducted by our research group. Briefly, this self-help leaflet aims to improve sleep by identifying and addressing sleep-related dysfunctional thinking by providing education about sleep, providing techniques to distract from intrusive worrisome thoughts at night, and providing guidelines for sleep-related stimulus control.

The duration of treatment will be one week and the follow-up period is at the end of the treatment period. Participants will be randomised using online software (where good sleepers will be randomised to treatment or no treatment).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Insomnia severity measured using the Insomnia Severity Index at one week post-intervention

Secondary outcome measures

1. Sleep continuity from sleep diaries throughout the intervention
2. Subjective mood measured using the PHQ-9 and GAD-7 at 1 week post-intervention

Overall trial start date

25/03/2020

Overall trial end date

06/04/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All participants must:
1. Be aged 18 years and above
2. Have a sufficient level of English comprehension to understand and complete questionnaires

Poor sleepers:
1. Must have difficulties in falling asleep, staying asleep, or awakening too early at least three nights per week, for a time period of between two weeks and three months
2. Must have distress or impairment caused by sleep loss
3. Both 1. and 2. must occur despite the individual having an adequate opportunity for sleep

Good sleepers:
1. No current sleep problems

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

75 (25 poor sleeper, 25 wait-list good sleeper controls, 25 good sleepers who do not receive the intervention).

Participant exclusion criteria

Poor sleepers:
1. Long-term (i.e. chronic) sleep problems (> 3 months)

Recruitment start date

04/05/2020

Recruitment end date

01/04/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northumbria University
Northumbria Sleep Research Laboratory
Newcastle upon Tyne
NE1 8ST
United Kingdom

Sponsor information

Organisation

Northumbria University

Sponsor details

Sunderland Building
Newcastle upon Tyne
NE1 8ST
United Kingdom
+44 (0)191 243 7108
samantha.king@northumbria.ac.uk

Sponsor type

University/education

Website

https://www.northumbria.ac.uk/

Funders

Funder type

University/education

Funder name

Northumbria University

Alternative name(s)

Northumbria University, Newcastle

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Dr Greg Elder (g.elder@northumbria.ac.uk) after a period of exclusive use (12 months). Our intended policy is that the research team will have exclusive use of the data for a period of 12 months from the end of the project, or until the data is published, if this is required alongside publications. Anonymised data will be provided and data will be made available upon application and the research team would control access in line with Northumbria University guidelines, however, data access will not reasonably be refused.

Intention to publish date

01/04/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/05/2020: Internal review. 22/04/2020: The following changes were made to the trial record: 1. The recruitment start date was changed from 06/04/2020 to 04/05/2020. 2. Ethics approval details added. 3. Due to current public health guidance, recruitment for this study has been paused. 02/04/2020: Trial’s existence confirmed by Northumbria University.