AWAKE Check: A UK study assessing sleep disorder risk in adults using online and pharmacy-based screening

ISRCTN	ISRCTN16640471
DOI	https://doi.org/10.1186/ISRCTN16640471
Secondary identifying numbers	Protocol: AWAKE v6.5, Ethics approval: Newcastle University REC Ref 63260/2023, OSF preregistration: https://osf.io/63c4u

Submission date: 30/09/2025
Registration date: 30/09/2025
Last edited: 30/09/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Sleep disorders such as insomnia and obstructive sleep apnoea (OSA) are common in the UK but are often under-recognised and untreated. Both conditions have major impacts on health, wellbeing, safety, and productivity. This study aims to estimate the proportion of UK adults at risk for insomnia, OSA, and comorbid insomnia and sleep apnoea (COMISA) using validated questionnaires delivered online. The project also seeks to raise awareness of sleep health by engaging people through community pharmacies, social media, and mass media.

Who can participate?
Adults aged 18 years and over who live in the UK and can complete an online survey in English. Participation is voluntary and open to both healthy volunteers and people who may already have sleep problems.

What does the study involve?
Participants complete a short web-based survey hosted on JotForm. The survey includes:
1. The Insomnia Severity Index (ISI) to assess insomnia risk
2. The STOP-Bang questionnaire to assess risk of obstructive sleep apnoea.
3. An optional Functional Outcomes of Sleep Questionnaire (FOSQ-10) to measure the impact of sleepiness on daily activities.
The survey takes about 5 minutes to complete. All questions are mandatory to ensure complete data, except for the optional field where participants may request an email copy of their responses. At the end, participants receive tailored feedback about their results and signposting to healthcare advice if at increased risk.

What are the possible benefits and risks of participating?
There are no direct health benefits to taking part, but participants may find it useful to learn more about their sleep health and possible next steps. The information gathered will help researchers and healthcare providers better understand the scale of sleep health needs in the UK. Risks are minimal: the survey is anonymous and non-invasive, and no treatment is given. Some participants may find questions about their sleep sensitive, but they can withdraw at any time by choosing not to submit the survey.

Where is the study run from?
The study is organised and coordinated by the British Society of Pharmacy Sleep Services (BSPSS), a UK-registered charity based in Lincoln.

When is the study starting and how long is it expected to run for?
May 2025 to April 2026

Who is funding the study?
This is an unfunded investigator-initiated study coordinated by BSPSS
Sefam Medical UK Ltd: £500 unconditional grant to support participant prize fund

Who is the main contact?
Adrian Zacher, start@awakecheck.co.uk

Study website

Contact information

Dr Adam Pattison Rathbone
Principal Investigator

Newcastle University
Newcastle
NE1 7RU
United Kingdom

ORCID ID	0000-0002-1005-0533
Phone	+44 (0)191 208 6000
Email	Adam.Rathbone@newcastle.ac.uk

Mr Adrian Zacher
Public, Scientific

4 Waterford Lane
Cherry Willingham
Lincoln
LN3 4AL
United Kingdom

ORCID ID	0000-0002-5855-3850
Phone	+44 (0)7769187168
Email	hello@bspss.org

Study information

Study design	Prospective observational cross-sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Charity/Voluntary sector, Community, Other
Study type	Prevention, Quality of life, Screening
Participant information sheet	https://awakecheck.co.uk/participant-information/
Scientific title	A prospective observational cross-sectional study assessing risk of insomnia and obstructive sleep apnoea in UK adults using validated screening tools (Insomnia Severity Index, STOP-Bang, and FOSQ-10)
Study acronym	AWAKE
Study objectives	1. To determine the prevalence of risk for insomnia and obstructive sleep apnoea (OSA) in a UK adult population using validated screening tools (Insomnia Severity Index and STOP-Bang questionnaire). 2. To identify the proportion of participants at risk of comorbid insomnia and sleep apnoea (COMISA). 3. To compare the prevalence of sleep disorder risk across defined subgroups (e.g. occupation, sex, BMI, recruitment channel, and geographic location). 4. To assess the functional impact of sleepiness on daily living using the Functional Outcomes of Sleep Questionnaire (FOSQ-10) in a sub-sample of respondents.
Ethics approval(s)	Approved 12/08/2025, Newcastle University Research Ethics Committee (King's Gate, Newcastle, NE1 7RU, United Kingdom; +44 (0)191 208 6000; res.policy@ncl.ac.uk), ref: 63260/2023
Health condition(s) or problem(s) studied	Insomnia disorder; Obstructive sleep apnoea (OSA); Comorbid insomnia and sleep apnoea (COMISA); Sleep-related functional impairment
Intervention	Participants will complete a single web-based survey (JotForm) including validated screening tools: the Insomnia Severity Index (ISI), the STOP-Bang questionnaire for obstructive sleep apnoea risk, and the optional Functional Outcomes of Sleep Questionnaire (FOSQ-10). On completion, participants receive tailored risk feedback and signposting to healthcare support if at elevated risk. Data collection occurs once at baseline, with no follow-up.
Intervention type	Behavioural
Primary outcome measure	1. Proportion of participants at high risk of insomnia, measured using the Insomnia Severity Index (ISI; score ≥15), assessed once at baseline (on survey completion). 2. Proportion of participants at high risk of obstructive sleep apnoea, measured using the STOP-Bang questionnaire (score ≥5), assessed once at baseline (on survey completion).
Secondary outcome measures	1. Proportion of participants at risk of comorbid insomnia and sleep apnoea (COMISA), defined by ISI score ≥15 and STOP-Bang score ≥3, assessed once at baseline (on survey completion). 2. Functional impairment due to sleepiness, measured using the Functional Outcomes of Sleep Questionnaire (FOSQ-10), assessed once at baseline (on survey completion). 3. Comparison of sleep disorder risk prevalence across subgroups (occupation, sex, BMI, recruitment channel, and geographic region), assessed once at baseline (on survey completion). 4. Geographic distribution of risk categories, analysed by the first three digits of participant postcodes, assessed once at baseline (on survey completion).
Overall study start date	19/05/2025
Completion date	30/04/2026

Eligibility

Participant type(s)	Healthy volunteer, Patient, Employee, Learner/student
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	5000
Key inclusion criteria	1. Adults aged 18 years or older 2. Resident in the United Kingdom 3. Able to access and complete an online survey in English 4. Occupation may include employee or learner/student (18+ years)
Key exclusion criteria	1. Individuals under the age of 18 years 2. Non-UK participants, identified through IP address location at survey entry 3. Incomplete survey responses (missing core outcome data)
Date of first enrolment	01/10/2025
Date of final enrolment	03/04/2026

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

British Society of Pharmacy Sleep Services

4 Waterford Lane
Cherry Willingham
Lincoln
LN3 4AL
United Kingdom

Sponsor information

British Society of Pharmacy Sleep Services (BSPSS)
Charity

4 Waterford Lane
Cherry Willingham
Lincoln
LN3 4AL
England
United Kingdom

Phone	+44 (0)7769187168
Email	hello@bspss.org
Website	https://bspss.org

Funders

Funder type

Other

Investigator initiated and funded

No information available

Sefam Medical UK Ltd. £500 unconditional grant to support participant prize fund

No information available

Results and Publications

Intention to publish date	30/04/2027
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Results will be submitted for publication in peer-reviewed academic journals and included in a PhD thesis at Vrije Universiteit Brussel. Findings will also be disseminated through conference presentations, professional networks in pharmacy and sleep medicine, and public engagement activities via the British Society of Pharmacy Sleep Services (BSPSS.org) website.
IPD sharing plan	Individual participant data will not be shared. Only aggregate, anonymised results will be published and reported in line with ethical approval.

Editorial Notes

30/09/2025: Study's existence confirmed by the Newcastle University Research Ethics Committee.