Sleep Revolution - evaluation of a novel diagnostic and therapeutic pathway for patients with obstructive sleep apnea
| ISRCTN | ISRCTN17539031 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17539031 |
| Secondary identifying numbers | SR 001.3 |
- Submission date
- 31/08/2023
- Registration date
- 23/02/2024
- Last edited
- 05/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Obstructive sleep apnea (OSA) is when your breathing stops and starts while you sleep, and is associated with various health complications such as a high risk of heart disease, high blood pressure and daytime sleepiness. Despite its negative impact and various associated illnesses, OSA remains poorly diagnosed and ineffectively treated. The EU-funded SLEEP REVOLUTION project is introducing an approach based on machine learning to assess OSA severity and treatment needs. The current study compares the standard care model of sleep apnea diagnosis with a novel approach to study sleep in the patients' homes for 3 nights instead of one single night. In order to analyse the data faster and more accurately, new computer-based analysis will be used to evaluate the large amount of data. It is one aim of the study to identify markers during sleep that are better at predicting patients symptoms of sleep problems compared to current diagnostic procedures. A novel sleep question will be developed and evaluated for the first time in this study. One important aspect of the current study is that 24 sleep centers in more than 15 European countries are involved in the study. Up to 1000 patients with suspected sleep apnea across Europe are intended to include in this study.
Who can participate?
Patients aged 18 years and over with suspected sleep apnea referred by their physicians to one of the study centers
What does the study involve?
The study compares the traditional way of sleep diagnosis with a comprehensive sleep study in the hospital or a simplified sleep study at home with a novel approach to perform a comprehensive sleep study for three nights at home. In the novel setting, the patient will be more participatory in the sleep diagnostic process, both by performing the test at home and by providing more information on actual sleep complaints and lifestyle factors. The outcome of those different diagnostic processes will be compared.
What are the possible benefits and risks of participating?
Sleep tests do not include any major risk, only skin lesions may occur through the placement of electrodes on the skin. More comprehensive sleep tests may cause discomfort without medical harm. The benefits include more detailed knowledge about sleep quality and the number of severity of sleep apnea events. Further, the new diagnostic principle has a strong focus on a variety of sleep-related symptoms and consequences, it is more patient-centred.
Where is the study run from?
Sahlgrenska University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
March 2020 to February 2025
Who is funding the study?
European Commission
Who is the main contact?
Ludger Grote, ludger.grote@lungall.gu.se
Contact information
Principal Investigator
Bruna Stråket 11
Göteborg
413 45
Sweden
 ORCID ID |
0000-0002-7405-1682 |
|---|---|
| Phone | +46 (0)709798111 |
| ludger.grote@lungall.gu.se |
Study information
| Study design | Multi-center two-arm randomized cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A randomized cross over trial exploring the Sleep Revolution diagnostic and therapeutic pathway in patients with obstructive sleep apnea |
| Study acronym | Sleep Revolution WP 8 study |
| Study hypothesis | The current study is a major work package within the overall Sleep Revolution (SR) project. The study focuses on the evaluation of the new SR pathway for sleep apnea diagnosis and treatment follow-up. The feasibility of the following new technologies including patient-related symptom assessment methodology, and data analysis approaches, will be evaluated: 1. Self-applied polysomnography 2. Diagnostic assessment over long time periods including 3 consecutive nights of advanced sleep testing, at least one week of testing with actigraphy, physical activity, sleep symptom questionnaire, and sleep diary 3. Artificial intelligence-based analysis of sleep tests for characterization of sleep, respiratory events and cardiovascular function with quality control by healthcare professionals (semi-automated process) 4. Digital platform for data transfer from the patient to the health care professional 5. Validation of new sleep parameters like hypoxic burden, sleep disturbance index and pulse wave derived cardiovascular indices against comorbidities, baseline symptoms, and response to treatment 6. To evaluate the novel European Sleep Questionnaire (ESQ) |
| Ethics approval(s) |
Submitted 13/11/2023, Swedish Ethical Review Authority (Box 2110, Uppsala, 75002, Sweden; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: 2023-03829-01 |
| Condition | Sleep apnea |
| Intervention | Study SR-001 is a multi-center, two-arm, cross-over study comparing the diagnostic impact and accuracy of two different diagnostic pathways on the outcome of diagnosis and continuous positive airway pressure (CPAP) treatment in patients with suspected obstructive sleep apnea (OSA). Patients referred to one of 24 sleep centers of the Escuela Superior de Arte y Diseño de Andalucía (ESADA) network participating in the Sleep Revolution project will be studied using both the clinical routine of OSA evaluation (standard care [SC]) and the novel Sleep Revolution-based diagnostic pathway including self-applied polysomnography over 3 nights, digitally based symptom evaluation, and actigraphy-based assessment of sleep-wake rhythm and physical activity (experimental condition). Randomisation is carried out in blocks of four patients, and a randomisation list will be distributed to each participating centre in the study. The randomisation list was generated by a publicly available service at https://www.sealedenvelope.com/simple-randomiser/v1/lists on 17 August 2023 with the seed for the randomization list of 275031337567920. Actual randomization will be performed at each study site by personnel otherwise not involved in the study. Standard sleep diagnostic procedure (standard care pathway): Single night polygraphy or polysomnography both at baseline. Limited numbers of questionnaire data. The experimental setting (Sleep Revolution pathway) includes three nights of self-applied polysomnography, app-based assessment of symptoms, sleep diary, cognitive function and physical activity. Actigraphy-based assessment of sleep-wake cycle and objective physical activity. In case of clinically relevant sleep apnea according to the results of the diagnostic assessment, patients will be offered treatment for sleep apnea with CPAP. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not applicable |
| Primary outcome measure | Staff time spent for the sleep apnea diagnostic pathway – comparison between Standard Care (SC) and the Sleep Revolution (SR) model in patients with suspected obstructive sleep apnea (OSA) from patient inclusion to final consultation with the sleep physician (units: minutes) |
| Secondary outcome measures | 1. Patient satisfaction and preference with the diagnostic work-up (score of the patient global impression scale and the patient preference question) at visit 1c: end of diagnostic procedure 2. Patient satisfaction with the resolution of the initial help request through diagnosis and treatment (only in patients with CPAP therapy, specific question in the European Sleep Questionnaire) at V3b: end of study follow-up visit 3. Number of OSA diagnoses, Positive Airway Pressure (PAP) treatment prescriptions, and non-PAP prescriptions by either pathway (number of patients in each group) at V1c and V3b 4. Number of patients with PAP failure (no acceptance/low adherence) by either pathway (number of patients in each group) at V3b 5. Prediction of PAP treatment responders in terms of adherence and symptom improvement by novel diagnostic parameters (SR versus SC) (predictor analysis of adherence with PAP treatment in h/night, conventional diagnostic markers versus novel diagnostic markers) at V3b 6. Association between sleep test output variables (polysomnography [PSG] and home sleep apnea test [HSAT]) (respiration, hypoxia, cardiovascular function, sleep) and symptoms/comorbidities obtained in SC and SR at V1c |
| Overall study start date | 01/03/2020 |
| Overall study end date | 28/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1000, according to power analysis (non-inferiority design) based on time estimates in SC and SR care models, 1000 patients need to be randomized (500 patients in each of the 2 diagnostic pathways) corresponding to 42 patients per ESADA study centre. An interim analysis will be performed after 500 patients to determine the final number of patients to be included. |
| Participant inclusion criteria | Main Inclusion Criteria: 1. Referral to the sleep center due to suspected obstructive sleep apnea as the main question for evaluation 2. Male or female aged 18 years and above 3. Willing and able to provide written informed consent 4. Willing and able to comply with the study design schedule and other requirements (e.g. no long-term travel conflicting with the planned visits throughout the study) |
| Participant exclusion criteria | Main Exclusion Criteria: 1. Any ongoing treatment for OSA or central sleep apnea (CSA) 2. Known significant hypercapnic respiratory failure due to chronic obstructive pulmonary disease or other respiratory condition 3. Any other clinically determined contraindication for PAP treatment 4. Patients participating in any type of weight loss treatment program 5. Unstable congestive heart failure or angina pectoris 6. Any other condition – to the judgement of the investigator – which potentially may jeopardize the completion of the study according to protocol 7. History of alcohol or drug abuse during the last year, substance use disorder at screening |
| Recruitment start date | 20/12/2023 |
| Recruitment end date | 31/01/2025 |
Locations
Countries of recruitment
- Belgium
- Croatia
- Cyprus
- Czech Republic
- Denmark
- Finland
- France
- Germany
- Greece
- Ireland
- Italy
- Poland
- Portugal
- Romania
- Sweden
- Türkiye
Study participating centre
Gothenburg University
Medicinaregatan 8B
Gothenburg
41346
Sweden
Sponsor information
Government
SDME 2/2
Brussels
B-1049
Belgium
| Phone | +32 (0)800 67 89 10 11 |
|---|---|
| daniellek@ru.is | |
| Website | http://ec.europa.eu/research/index.cfm?pg=dg |
"ROR" |
https://ror.org/01ef4as46 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | It is planned to publish the results of this major study on approximately 1000 patients in several papers submitted to high-ranking medical peer-reviewed journals after the finalization of the study in 2025. |
| IPD sharing plan | The datasets generated during the current study may be available upon reasonable request from Danielle Knieriem (daniellek@ru.is). Further details will be published at a later stage. |
Editorial Notes
05/04/2024: Sponsor contact details updated.
02/01/2024: Study's existence confirmed by the Swedish Ethical Review Authority.
