Obstructive Sleep ApneaNCT05380726
Effectiveness of an E-health Intervention in Patients With Obstructive Sleep Apnoea
A study testing Patient education in people with Obstructive Sleep Apnea, run by Universitat de Lleida at 1 site in Spain.
Trial summary
Obstructive sleep apnoea is a highly burdensome condition that not only impairs function but also confers a risk of cardiovascular disease. This is particularly evident among those who are poorly compliant with continuous positive airway pressure ventilation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 30 Mar 2025
- Phase
- Interventional
- 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
Who may be able to join
- Moderate OSA (apnoea-hypoapnoea index (AHI)) of 15-30
- Hypertension diagnosed by 24h-ABPM
- Men and women aged ≥ 18 years
- Spanish and/or Catalan can be read, written, and spoken
- Currently residing in Lleida (Spain)
- Own or have access to mobile phone (Android and IOS)
Who cannot join
- Previous diagnosis of OSA / use of CPAP
- Pregnancy
- Body mass index (BMI) below 17
- Subjects undergoing bariatric intervention or on the waiting list for it
- Not being able to fill out questionnaires
- Incapacity to handle technology
Trial locations and contacts
1 site in 1 country.
Fran Valenzuela-Pascual contact
Spain1 site, 1 recruiting
- Recruiting
Biomedical Research Institure of Lleida
Lleida, 25198
Oriol Martínez-Navarro, 619562618 ext. +34, omartinez@irblleida.cat
Fran Valenzuela-Pascual, fran.valenzuela@udl.cat
About this study
Official title: Effectiveness of an E-health Intervention on Blood Pressure, Sleep Quality and Physical Activity in Patients With Obstructive Sleep Apnoea: A Sequential Exploratory Mixed-method Research Protocol With a Realist Evaluation Approach
Obstructive sleep apnoea is a highly burdensome condition that not only impairs function but also confers a risk of cardiovascular disease. This is particularly evident among those who are poorly compliant with continuous positive airway pressure ventilation therapy. In the management of a chronic and frequent pathology such as OSA, it is necessary to have personalized programs that implement new technology-based tools to improve the comprehensive management of the patient in order to reduce the morbidity associated with this disease.
Read the detailed description
Objectives: The purpose of this study is to evaluate the effectiveness of eHealth tools in managing obstructive sleep apnoea pathophysiological consequences and how they impact the quality of life after 3 months of intervention in adults.Qual: To identify OSA patients' beliefs concerning their condition and its treatment. Connection: To construct the information resources that the mobile application will offer using the QUAL results. Quan: Objective sleep parameters, Subjective sleep quality , Daytime sleepiness Physical activity habits, Quality of life related to health, Self-efficacy and empowerment, Anthropometry, Adherence to the program/treatment, Cost / benefit.
Design: Mixed-method sequential exploratory design with realist evaluation approach.
Population and sample: Patients referred to the sleep unit of the Arnau de Vilanova - Santa María Hospital for a suspected diagnosis of obstructive sleep apnoea. For the qualitative phase, the subjects will be contacted and invited to participate in a semi-structured personal interview related to the gaps and knowledge needs that these types of patients have about the pathology itself and its management. The quantitative phase will be a randomized controlled trial. Subjects will be randomly assigned using a simple random technique. The experimental group will receive an eHealth intervention through an electronic wristband device and access to the eHealth tool (phone application) that will offer specific recommendations on health, physical activity and hygienic-dietary advice. All these recommendations will be based on the information obtained in the qualitative phase and the parameters mesured by the electronic wristband device in real time. Those in the control group will receive the same electronic wristband device and the same access to the ehealth tool, but the information received will be based on the general hygienic-dietary measures that the sleep unit provides to all patients.
This research belongs to Moore4Medical project. It has received funding within the Electronic Components and Systems for European Leadership Joint Undertaking (ECSEL JU) in collaboration with the European Union's H2020 Framework Programme (H2020/2014-2020) and National Authorities, under grant agreement H2020-ECSEL-2019-IA-876190.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Patient education
- Keywords
- obstructive sleep apnoea, eHealth tools, patient education, blood pressure, therapeutic exercise
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationBehavioural
Also called hygienic-dietary measures, sleep related habits, physical activity
The intervention received will be a specific patient education for each subject depending on the parameters assessed by the electronic wrist device in real-time. The recommendation are related to different educational topics as hygienic-dietary measures and sleep related habits, or physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | A pilot study will be conducted for 2 months with a sample of 10 participants, in order to gather initial data to test the algorithm from the eHealth tool. During the QUAN phase the algorithm will provide individualized feedback and responses to the patients based on their different variables analyzed in real-time by the wrist receiver device: cardiovascular parameters, sleep quality and structure of sleep, physical activity, oxygen saturation.
The eHealth tool will contain all the educational materials developed by the researchers of the study. Depending on the information received from the electronic wrist device the eHealth tool will make recommendations of educational topics as hygienic-dietary measures, sleep related habits, or physical activity. The information provided in this regard will be dependent upon the subjects' knowledge gaps/beliefs identified in the QUAL phase and the parameters measures by the electronic wrist device in each subject. Receives: Behavioral: Patient education |
| Control group | Active comparator | In the control group, the participants will be provided with the same electronic wrist device and access to the eHeatlh tool as the experimental group. However, the electronic wrist device will not provide feedback based on the parameters of each individual. The information provided by the eHealth tool will be general information from the sleep unit of the Arnau de Vilanova - Santa María Hospital instead of the materials developed from the QUAL phase. Receives: Behavioral: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Blood pressure: Blood pressure changes after 3 months of intervention, measured with a holter blood pressure recorder (Spacelabs 90217A, Hertford: UK).
Measured: Pre-post (after 3 months of intervention)
Secondary outcomes (10)
Polysgraphy
Twe will use respiratory polygraphy (Embletta, ResMed, Bella Vista, NSW, Australia) to assess the AHI, oxygen desaturation index (ODI, >4%), minimum and mean oxygen saturation (SaO2), the average duration of events and percentage of time with SaO2 <90%.
Measured: Pre-post (after 3 months of intervention)
The Pittsburgh Sleep Quality Inventory (PSQI)
) is a 19-item list of items used to measure sleep quality and disturbances over the past month. As part of the PSQI, various sleep characteristics are measured, including sleep latency (i.e., the amount of time taken to fall asleep). On a scale of 0 to 3, each item is scored (0 = not during the past month; 1 = less than once a week; 2 = once or twice a week; and 3 = three or more times a week) (49). These scores are summed to generate an overall score. The higher the scores, the lower the quality of sleep. A score of more than five indicates poor sleep quality. With an alpha value of 0.83, the PSQI has demonstrated reliability in its internal consistency
Measured: Pre-post (after 3 months of intervention)
Daytime sleepiness assessment
Subjective sleepiness will be assessed using the "Epworth Sleepiness Scale (ESS)" validated in Spanish. This is a questionnaire that contains eight items that indicate the probability of falling asleep during activities of daily living, ranging from 0 (never) to 3 (high probability). Normal values will be established between 2 and 10, with values greater than 10 indicating daytime sleepiness
Measured: Pre-post (after 3 months of intervention)
Six-minute walk test (6MWT)
The 6MWT test evaluates the respiratory, cardiovascular, metabolic, musculoskeletal, and sensorineural responses to exercise. It is considered a useful tool for assessing the functional capacity of patients with chronic respiratory and/or cardiovascular diseases and is used to assess the submaximal level of functional performance at a similar level required for daily physical activities (55). 6MWT measures the maximum distance an individual is able to walk as fast as possible (not run) using their usual walking aids if any, and take their regular medications before the test, in 6 minutes. The patients can rest is allowed as required but the time is not stopped. The 6MWT is normally carried out in a corridor of 30 meters in length, on a hard and flat surface, and preferably indoors
Measured: Pre-post (after 3 months of intervention)
Empowerment and motivation for change
The Spanish version of the Health Empowerment Scale will be used to measure empowerment, while motivation will be measured using the Self-Efficacy Scale for Physical Activity
Measured: Pre-post (after 3 months of intervention)
Health-related quality of life
This will be assessed using the EuroQol-5D (EQ-5D) questionnaire in its valid Spanish version
Measured: Pre-post (after 3 months of intervention)
Anthropometry measurement 1
Body mass index (BMI) (kg / m 2). In order to calculate BMI, Weight (kg) and height (m) will be measured using a scale and a standard stadiometer.
Measured: Pre-post (after 3 months of intervention)
Anthropometry measurements 2
Waist-to-hip ratio. The waist, and hip circumferences, measured in triplicate and averaged, will be taken into consideration.
Measured: Pre-post (after 3 months of intervention)
Adherence to the program/treatment
Scale of adherence and number of entries to the telephone application.
Measured: Post intervention (after 3 months)
Cost-benefit
Comparison through the final costs of the current project and the studied costs of conservative treatment according to the research by Tarraubella et al. (2018)
Measured: Post intervention (after 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Sep 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
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 Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- We will carry out a mixed-method exploratory sequential investigation with a realistic evaluation approach. The use of this mixed methodology allows us to use the strengths of the qualitative and quantitative phases while reducing their weaknesses. Specifically, the sequential exploratory design includes an initial qualitative phase followed by a quantitative phase, with the aim of developing an educational tool. In this project it is proposed that both phases should have the same relevance (QUAL-QUAN) for the development of the educational tool and the development of the study should be carried out in three stages. During all phases of the project, the realistic evaluation approach will be taken into account, especially after the intervention, carrying out different semi-structured interviews and focus groups to redefine the cycle and optimize future research.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recerca Biomèdica de Lleida, Horizon 2020 - European Commission
- Responsible party
- Principal investigator, Francesc Valenzuela Pascual, Universitat de Lleida
- Investigators
- Fran Valenzuela-Pascual, PhD, Principal investigator, Biomedical Research Institute of Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380726
- Sponsor's protocol ID
- Moore4Medical
- Status last verified
- May 2024
- First submitted
- 26 Jan 2022
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valenzuela-Pascual F, Verdejo-Amengual FJ, Martinez-Navarro O, Blanco-Blanco J, El Arab RA, Rubinat-Arnaldo E, Masbernat-Almenara M, Rubi-Carnacea F, Manuel Marti B, Barbe F, Sanchez-de-la-Torre M. Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodology of the Moore4Medical trial protocol. BMJ Open Respir Res. 2024 Dec 18;11(1):e001889. doi: 10.1136/bmjresp-2023-001889.
PubMed 39694678
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an E-health Intervention on Blood Pressure, Sleep Quality and Physical Activity in Patients With Obstructive Sleep Apnoea: A Sequential Exploratory Mixed-method Research Protocol With a Realist Evaluation Approach
- ClinicalTrials.gov ID
- NCT05380726
- Acronym / sponsor ID
- Moore4Medical
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnoea, eHealth tools, patient education, blood pressure, therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Collaborators
- Institut de Recerca Biomèdica de Lleida, Horizon 2020 - European Commission
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 19 May 2022 (actual)
- 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.
Obstructive sleep apnoea is a highly burdensome condition that not only impairs function but also confers a risk of cardiovascular disease. This is particularly evident among those who are poorly compliant with continuous positive airway pressure ventilation therapy. In the management of a chronic and frequent pathology such as OSA, it is necessary to have personalized programs that implement new technology-based tools to improve the comprehensive management of the patient in order to reduce the morbidity associated with this disease.
Detailed description
Objectives: The purpose of this study is to evaluate the effectiveness of eHealth tools in managing obstructive sleep apnoea pathophysiological consequences and how they impact the quality of life after 3 months of intervention in adults.Qual: To identify OSA patients' beliefs concerning their condition and its treatment. Connection: To construct the information resources that the mobile application will offer using the QUAL results. Quan: Objective sleep parameters, Subjective sleep quality , Daytime sleepiness Physical activity habits, Quality of life related to health, Self-efficacy and empowerment, Anthropometry, Adherence to the program/treatment, Cost / benefit.
Design: Mixed-method sequential exploratory design with realist evaluation approach.
Population and sample: Patients referred to the sleep unit of the Arnau de Vilanova - Santa María Hospital for a suspected diagnosis of obstructive sleep apnoea. For the qualitative phase, the subjects will be contacted and invited to participate in a semi-structured personal interview related to the gaps and knowledge needs that these types of patients have about the pathology itself and its management. The quantitative phase will be a randomized controlled trial. Subjects will be randomly assigned using a simple random technique. The experimental group will receive an eHealth intervention through an electronic wristband device and access to the eHealth tool (phone application) that will offer specific recommendations on health, physical activity and hygienic-dietary advice. All these recommendations will be based on the information obtained in the qualitative phase and the parameters mesured by the electronic wristband device in real time. Those in the control group will receive the same electronic wristband device and the same access to the ehealth tool, but the information received will be based on the general hygienic-dietary measures that the sleep unit provides to all patients.
This research belongs to Moore4Medical project. It has received funding within the Electronic Components and Systems for European Leadership Joint Undertaking (ECSEL JU) in collaboration with the European Union's H2020 Framework Programme (H2020/2014-2020) and National Authorities, under grant agreement H2020-ECSEL-2019-IA-876190.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- We will carry out a mixed-method exploratory sequential investigation with a realistic evaluation approach. The use of this mixed methodology allows us to use the strengths of the qualitative and quantitative phases while reducing their weaknesses. Specifically, the sequential exploratory design includes an initial qualitative phase followed by a quantitative phase, with the aim of developing an educational tool. In this project it is proposed that both phases should have the same relevance (QUAL-QUAN) for the development of the educational tool and the development of the study should be carried out in three stages. During all phases of the project, the realistic evaluation approach will be taken into account, especially after the intervention, carrying out different semi-structured interviews and focus groups to redefine the cycle and optimize future research.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Patient educationA pilot study will be conducted for 2 months with a sample of 10 participants, in order to gather initial data to test the algorithm from the eHealth tool. During the QUAN phase the algorithm will provide individualized feedback and responses to the patients based on their different variables analyzed in real-time by the wrist receiver device: cardiovascular parameters, sleep quality and structure of sleep, physical activity, oxygen saturation. The eHealth tool will contain all the educational materials developed by the researchers of the study. Depending on the information received from the electronic wrist device the eHealth tool will make recommendations of educational topics as hygienic-dietary measures, sleep related habits, or physical activity. The information provided in this regard will be dependent upon the subjects' knowledge gaps/beliefs identified in the QUAL phase and the parameters measures by the electronic wrist device in each subject. |
| Control group | Active comparator | Behavioral: Patient educationIn the control group, the participants will be provided with the same electronic wrist device and access to the eHeatlh tool as the experimental group. However, the electronic wrist device will not provide feedback based on the parameters of each individual. The information provided by the eHealth tool will be general information from the sleep unit of the Arnau de Vilanova - Santa María Hospital instead of the materials developed from the QUAL phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Moderate OSA (apnoea-hypoapnoea index (AHI)) of 15-30
- Hypertension diagnosed by 24h-ABPM
- Men and women aged ≥ 18 years
- Spanish and/or Catalan can be read, written, and spoken
- Currently residing in Lleida (Spain)
Key exclusion criteria (6 listed)
- Previous diagnosis of OSA / use of CPAP
- Pregnancy
- Body mass index (BMI) below 17
- Subjects undergoing bariatric intervention or on the waiting list for it
- Not being able to fill out questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient educationAlso: hygienic-dietary measures, sleep related habits, physical activityThe intervention received will be a specific patient education for each subject depending on the parameters assessed by the electronic wrist device in real-time. The recommendation are related to different educational topics as hygienic-dietary measures and sleep related habits, or physical activity. | Behavioural | Control group, Experimental group |
Primary outcome
Blood pressure
Time frame: Pre-post (after 3 months of intervention)
Blood pressure: Blood pressure changes after 3 months of intervention, measured with a holter blood pressure recorder (Spacelabs 90217A, Hertford: UK).
10 secondary outcomes
Polysgraphy
Time frame: Pre-post (after 3 months of intervention)
The Pittsburgh Sleep Quality Inventory (PSQI)
Time frame: Pre-post (after 3 months of intervention)
Daytime sleepiness assessment
Time frame: Pre-post (after 3 months of intervention)
Six-minute walk test (6MWT)
Time frame: Pre-post (after 3 months of intervention)
Empowerment and motivation for change
Time frame: Pre-post (after 3 months of intervention)
Health-related quality of life
Time frame: Pre-post (after 3 months of intervention)
Anthropometry measurement 1
Time frame: Pre-post (after 3 months of intervention)
Anthropometry measurements 2
Time frame: Pre-post (after 3 months of intervention)
Adherence to the program/treatment
Time frame: Post intervention (after 3 months)
Cost-benefit
Time frame: Post intervention (after 3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Derived from this study: PubMed 39694678Valenzuela-Pascual F, Verdejo-Amengual FJ, Martinez-Navarro O, Blanco-Blanco J, El Arab RA, Rubinat-Arnaldo E, Masbernat-Almenara M, Rubi-Carnacea F, Manuel Marti B, Barbe F, Sanchez-de-la-Torre M. Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodology of the Moore4Medical trial protocol. BMJ Open Respir Res. 2024 Dec 18;11(1):e001889. doi: 10.1136/bmjresp-2023-001889.
- Individual participant dataSharing planned: No
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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.
Fran Valenzuela-Pascual contact
Fran Valenzuela-Pascual, PhD principal investigator
Biomedical Research Institute of Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Obstructive Sleep Apnea, run by Universitat de Lleida at 1 site in Spain.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 May 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oriol o Martínez-Navarro (619562618 ext. +34, omartinez@irblleida.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Pre-post (after 3 months of intervention)). 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 NCT05380726, 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 10 May 2024.