Obstructive Sleep ApneaTeleVALNCT05495347
Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring
An observational study of Obstructive Sleep Apnea and Positive Airway Pressure, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
Trial summary
The present study aims to determine to what extent remote monitoring of PAP related to patients' clinical parameters is able to provide relevant data on predictors of compliance, subgroups of patients who may benefit from this technological tool, variations in AHI over time, occurrence of central events at the start… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstructive Sleep Apnea, Positive Airway Pressure
- What is being tested?
- patients diagnosed with OSA
- How many people
- 2,500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 31 Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients diagnosed with Obstructive Sleep Apnea (OSA)
Who may be able to join
- All patients diagnosed with OSA since March 2020 with indication for treatment with PAP have been telemonitored on an ongoing basis since initiation of therapy continuing to be telemonitored at the current time.
Who cannot join
- Undiagnosed OSA patients
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Monica Gonzalez, monica.gonzalezm@scsalud.es
About this study
Official title: Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring: TeleVAL Study
The present study aims to determine to what extent remote monitoring of PAP related to patients' clinical parameters is able to provide relevant data on predictors of compliance, subgroups of patients who may benefit from this technological tool, variations in AHI over time, occurrence of central events at the start of therapy and, in short, to shed new light on this disease and its treatment, all within the application of continuous positive pressure therapy in the real world.
Among the intended objectives is the identification of phenotypes involved in the use and efficacy of PAP therapy: development of a predictive model, as well as the evaluation of the impact of long-term telemonitoring of patients with Obstructive Sleep Apnea (OSA).
Read more
The study initially arose from the need to diagnose, treat and follow up patients with suspected OSA in compliance with the social distancing rules imposed by the COVID-19 pandemic.
It is an ambispective cohort study, with retrospective data collection from the start date of the pandemic (March 2020) to December 2021, and prospective data collection from the approval of the protocol to December 2022.
- Conditions
- Obstructive Sleep Apnea, Positive Airway Pressure
- Being tested
- patients diagnosed with OSA
- Keywords
- telemonitoring, big data
- 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.
patients diagnosed with OSAOther
All patients diagnosed with OSA since March 2020 with an indication for treatment with PAP have been telemonitored permanently since the start of therapy and continue to be telemonitored at the present time. Data are sent remotely daily to the telemonitoring platform.
| Study group | Role | What they receive |
|---|---|---|
| Registry of patients | Not described Receives: Other: patients diagnosed with OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the phenotypes involved
Determine the emergent CSA appearance in relation to PAP treatment.
Measured: pandemic start date March 2020 until December 2022.
Secondary outcomes (5)
Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressure
According to Built in software (BIS) of the equipment
Measured: pandemic start date March 2020 until December 2022.
Establish the Profile of patients who at the first connection to the TM achieved the optimal therapeutic pressure
According to Built in software (BIS) of the equipment
Measured: pandemic start date March 2020 until December 2022.
Variations in AHI during the first year of follow-up and their relationship with patient characteristics.
Measured: pandemic start date March 2020 until December 2022.
Time to achieve the optimal therapeutic pressure described after the first connection
Number of modifications required and their relationship with patient subgroups.
Measured: pandemic start date March 2020 until December 2022.
Evaluation of the impact of long-term telemonitoring of patients with OSA
Number of acesses and interventions made to the telemonitoring platform/year and time invested
Measured: pandemic start date March 2020 until December 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495347
- Sponsor's protocol ID
- TeleVAL
- Acronym
- TeleVAL
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring: TeleVAL Study
- ClinicalTrials.gov ID
- NCT05495347
- Acronym / sponsor ID
- TeleVAL / TeleVAL
- Conditions
- Obstructive Sleep Apnea, Positive Airway Pressure
- Keywords
- telemonitoring, big data
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Aug 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.
The present study aims to determine to what extent remote monitoring of PAP related to patients' clinical parameters is able to provide relevant data on predictors of compliance, subgroups of patients who may benefit from this technological tool, variations in AHI over time, occurrence of central events at the start of therapy and, in short, to shed new light on this disease and its treatment, all within the application of continuous positive pressure therapy in the real world.
Among the intended objectives is the identification of phenotypes involved in the use and efficacy of PAP therapy: development of a predictive model, as well as the evaluation of the impact of long-term telemonitoring of patients with Obstructive Sleep Apnea (OSA).
The study initially arose from the need to diagnose, treat and follow up patients with suspected OSA in compliance with the social distancing rules imposed by the COVID-19 pandemic.
It is an ambispective cohort study, with retrospective data collection from the start date of the pandemic (March 2020) to December 2021, and prospective data collection from the approval of the protocol to December 2022.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registry of patients | – | Other: patients diagnosed with OSA |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with Obstructive Sleep Apnea (OSA)
Key inclusion criteria (1 listed)
- All patients diagnosed with OSA since March 2020 with indication for treatment with PAP have been telemonitored on an ongoing basis since initiation of therapy continuing to be telemonitored at the current time.
Key exclusion criteria (1 listed)
- Undiagnosed OSA patients
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 |
|---|---|---|
| patients diagnosed with OSAAll patients diagnosed with OSA since March 2020 with an indication for treatment with PAP have been telemonitored permanently since the start of therapy and continue to be telemonitored at the present time. Data are sent remotely daily to the telemonitoring platform. | Other | Registry of patients |
Primary outcome
Characterize the phenotypes involved
Time frame: pandemic start date March 2020 until December 2022.
Determine the emergent CSA appearance in relation to PAP treatment.
5 secondary outcomes
Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressure
Time frame: pandemic start date March 2020 until December 2022.
Establish the Profile of patients who at the first connection to the TM achieved the optimal therapeutic pressure
Time frame: pandemic start date March 2020 until December 2022.
Variations in AHI during the first year of follow-up and their relationship with patient characteristics.
Time frame: pandemic start date March 2020 until December 2022.
Time to achieve the optimal therapeutic pressure described after the first connection
Time frame: pandemic start date March 2020 until December 2022.
Evaluation of the impact of long-term telemonitoring of patients with OSA
Time frame: pandemic start date March 2020 until December 2022.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Positive Airway Pressure, run by Instituto de Investigación Marqués de Valdecilla 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 1 inclusion and 1 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 Aug 2022. 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 monica Gonzalez (+34942203389, monica.gonzalezm@scsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the phenotypes involved (time frame: pandemic start date March 2020 until December 2022.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2022.