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Sleep Apnea, ObstructiveTHINKNCT04300166

Telemedicine and Humidification for Cpap IN Osas Key Treatment (THINK Study)

A study testing Telemedicine & Humidification in people with Sleep Apnea, Obstructive and OSA, run by Andrea Romigi.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of the study is to test the role of telemedicine combined with humidification to check CPAP treatment during the first month to improve adherence and reduce unsolved side effects of therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sleep Apnea, Obstructive, OSA, Sleep
What is being tested?
Telemedicine & Humidification
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
1 Jun 2020to 1 Jun 2022
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

None listed.

Who cannot join

  • Age <18 years
  • Unable to communicate in Italian
  • Previous usage of CPAP treatment
  • Alcohol consumption > 4 units >4 times a week
  • Acute manifestation of psychiatric diseases
  • Life expectancy of < 6 months for any reason
  • Surgical obesity treatment planned within the next 6 months
  • Predominantly Central sleep apnea and cheyne stokes respiration

Trial locations and contacts

No sites are listed yet.

Andrea Romigi, PhD contact

+390865929636

andrea.romigi@neuromed.it

About this study

Official title: Effects of Telemedicine and Humidification for Continous Positive Airway Pressure (CPAP) in OSAS.

The goal of the study is to test the role of telemedicine combined with humidification to check CPAP treatment during the first month to improve adherence and reduce unsolved side effects of therapy.

Read the detailed description

The primary goal of OSAS therapy is to obtain CPAP adaptation for the highest amount of OSAS patients to reduce the proportion of untreated OSAS in the population. This object is important considering that a longer duration of CPAP treatment is linked with better daytime functioning and metabolic and blood pressure effects of CPAP. The main endpoints will be CPAP usage (defined as the proportion of night with CPAP usage ≥1h); CPAP adherence (defined as the proportion of night with CPAP usage ≥4h); the average nightly usage of CPAP (hour/night); CPAP efficacy (defined as AHI and ESS score). Each measure will be performed after 1 week, 1 month and 6 months.

Being tested
Telemedicine & Humidification
Keywords
Telemedicine, CPAP
Medical subject headings
Sleep Apnea, Obstructive, Sleep Wake Disorders, Disorders of Excessive Somnolence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine & HumidificationDevice

    Wireless control of CPAP usage, adherence, leakage and humidifier usage

Study groups in NCT04300166
Study groupRoleWhat they receive
Telemedicine & Humidification InterventionActive comparatorIn the telemedicine intervention arm, a telemetry device is instructed and attached to the CPAP. Patients are instructed to use CPAP every night. Data of the CPAP are downloaded to the internet once daily. On week days, a nurse/sleep technologist is checking the downloaded data three times per week. The contacts will be due to: 1. CPAP usage <4h/ night for 3 consecutive night 2. the median leakage was above 0.4 L/sec on 3 consecutive nights The nurse/sleep technologist informs the patient of the problem observed, asks for explanations and gives advice on possibilities to solve the problem. The common problems and the respective solutions (Dry mouth/throat, nasal congestion, skin irritation, conjunctivitis, headache, loss of benefits) will be discussed. The patient is encouraged to use CPAP every night. In the case of adherence >4h/night and acceptable leakage, a congratulatory message is sent to the patient via sms or e-mail.
Receives: Device: Telemedicine & Humidification
Control without Telemedicine & humidificationNo interventionIn the control arm, no wireless telemedicine and humidifier will be used with CPAP but data stored in the CPAP machine are collected at the follow-up visit after 1 month

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CPAP usage

    defined as the proportion of night with CPAP usage ≥1h

    Measured: 1 week

  2. CPAP usage

    defined as the proportion of night with CPAP usage ≥1h

    Measured: 1 month

  3. CPAP usage

    defined as the proportion of night with CPAP usage ≥1h

    Measured: 6 months

  4. CPAP adherence

    defined as the proportion of night with CPAP usage ≥4h

    Measured: 1 week

  5. CPAP adherence

    defined as the proportion of night with CPAP usage ≥4h

    Measured: 1 month

  6. CPAP adherence

    defined as the proportion of night with CPAP usage ≥4h

    Measured: 6 months

Secondary outcomes (3)

  1. average nightly usage of CPAP

    (hour/night)

    Measured: 1 week

  2. average nightly usage of CPAP

    (hour/night)

    Measured: 1 month

  3. average nightly usage of CPAP

    (hour/night)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2020
  2. Study start1 Jun 2020 (estimated)
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Jun 2022 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04300166
Sponsor's protocol ID
ongoing
Acronym
THINK
Status last verified
Mar 2020
First submitted
5 Mar 2020
Last updated
9 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Qaseem A, Holty JE, Owens DK, Dallas P, Starkey M, Shekelle P; Clinical Guidelines Committee of the American College of Physicians. Management of obstructive sleep apnea in adults: A clinical practice guideline from the American College of Physicians. Ann Intern Med. 2013 Oct 1;159(7):471-83. doi: 10.7326/0003-4819-159-7-201310010-00704.

    PubMed 24061345

  • Dorkova Z, Petrasova D, Molcanyiova A, Popovnakova M, Tkacova R. Effects of continuous positive airway pressure on cardiovascular risk profile in patients with severe obstructive sleep apnea and metabolic syndrome. Chest. 2008 Oct;134(4):686-692. doi: 10.1378/chest.08-0556. Epub 2008 Jul 14.

    PubMed 18625666

  • Smith I, Nadig V, Lasserson TJ. Educational, supportive and behavioural interventions to improve usage of continuous positive airway pressure machines for adults with obstructive sleep apnoea. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007736. doi: 10.1002/14651858.CD007736.

    PubMed 19370691

  • Bakker JP, Wang R, Weng J, Aloia MS, Toth C, Morrical MG, Gleason KJ, Rueschman M, Dorsey C, Patel SR, Ware JH, Mittleman MA, Redline S. Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial. Chest. 2016 Aug;150(2):337-45. doi: 10.1016/j.chest.2016.03.019. Epub 2016 Mar 24.

    PubMed 27018174

  • Hwang D, Chang JW, Benjafield AV, Crocker ME, Kelly C, Becker KA, Kim JB, Woodrum RR, Liang J, Derose SF. Effect of Telemedicine Education and Telemonitoring on Continuous Positive Airway Pressure Adherence. The Tele-OSA Randomized Trial. Am J Respir Crit Care Med. 2018 Jan 1;197(1):117-126. doi: 10.1164/rccm.201703-0582OC.

    PubMed 28858567

  • Farre R, Navajas D, Montserrat JM. Is Telemedicine a Key Tool for Improving Continuous Positive Airway Pressure Adherence in Patients with Sleep Apnea? Am J Respir Crit Care Med. 2018 Jan 1;197(1):12-14. doi: 10.1164/rccm.201709-1791ED. No abstract available.

    PubMed 28926279

  • Hoet F, Libert W, Sanida C, Van den Broecke S, Bruyneel AV, Bruyneel M. Telemonitoring in continuous positive airway pressure-treated patients improves delay to first intervention and early compliance: a randomized trial. Sleep Med. 2017 Nov;39:77-83. doi: 10.1016/j.sleep.2017.08.016. Epub 2017 Sep 30.

    PubMed 29157591

  • Frasnelli M, Baty F, Niedermann J, Brutsche MH, Schoch OD. Effect of telemetric monitoring in the first 30 days of continuous positive airway pressure adaptation for obstructive sleep apnoea syndrome - a controlled pilot study. J Telemed Telecare. 2016 Jun;22(4):209-14. doi: 10.1177/1357633X15598053. Epub 2015 Aug 6.

    PubMed 26253747

  • Lugo V, Villanueva JA, Garmendia O, Montserrat JM. The role of telemedicine in obstructive sleep apnea management. Expert Rev Respir Med. 2017 Sep;11(9):699-709. doi: 10.1080/17476348.2017.1343147. Epub 2017 Jun 29.

    PubMed 28621155

  • Pepin JL, Tamisier R, Hwang D, Mereddy S, Parthasarathy S. Does remote monitoring change OSA management and CPAP adherence? Respirology. 2017 Nov;22(8):1508-1517. doi: 10.1111/resp.13183.

    PubMed 29024308

  • Schoch OD, Baty F, Boesch M, Benz G, Niedermann J, Brutsche MH. Telemedicine for Continuous Positive Airway Pressure in Sleep Apnea. A Randomized, Controlled Study. Ann Am Thorac Soc. 2019 Dec;16(12):1550-1557. doi: 10.1513/AnnalsATS.201901-013OC.

    PubMed 31310575

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine & Humidification in people with Sleep Apnea, Obstructive and OSA, run by Andrea Romigi.

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 0 inclusion and 8 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 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

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 Andrea Romigi, PhD (+390865929636, andrea.romigi@neuromed.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CPAP usage (time frame: 1 week). The study lists 6 primary outcomes in all. 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 NCT04300166, which also lists 11 linked publications.

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 9 Mar 2020.

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