Clinical trial NCT04300166: Telemedicine and Humidification for Cpap IN Osas Key Treatment (THINK Study)
Official title: Effects of Telemedicine and Humidification for Continous Positive Airway Pressure (CPAP) in OSAS.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
OSA
Sleep
Sleep Disorder
Hypersomnia
Keywords: Telemedicine
CPAP
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
Collaborators: name: Sleep Apnoea Italian Patient Association
First posted: 2020-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria: • Consecutive symptomatic OSAS patients with an AHI and an oxygen desaturation index (ODI) of \>15/h in polysomnography (PSG) or Home Sleep Test (HST) consenting to start long term CPAP treatment.

Exclusion Criteria:

* 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

Primary outcomes:
measure: CPAP usage
timeFrame: 1 week
measure: CPAP usage
timeFrame: 1 month
measure: CPAP usage
timeFrame: 6 months
measure: CPAP adherence
timeFrame: 1 week
measure: CPAP adherence
timeFrame: 1 month
measure: CPAP adherence
timeFrame: 6 months
Secondary outcomes:
measure: average nightly usage of CPAP
timeFrame: 1 week
measure: average nightly usage of CPAP
timeFrame: 1 month
measure: average nightly usage of CPAP
timeFrame: 6 months
Other outcomes:
measure: CPAP efficacy: Apnea Hypopnea Index (AHI)
timeFrame: 6 months
measure: Daytime somnolence
timeFrame: 6 months
measure: Mask leakage
timeFrame: 6 months
measure: Adverse effects on CPAP
timeFrame: 6 months
measure: Overall Nocturnal Sleep quality
timeFrame: 6 months
Locations:
Study officials:
affiliation: IRCCS Neuromed
name: Diego Centonze, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.