Sleep Clinical Trial
— THINKOfficial 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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | June 1, 2022 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Andrea Romigi | Sleep Apnoea Italian Patient Association |
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. — View 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):686-92. doi: 10.1378/chest.08-0556. Epub 2008 Jul 14. — View Citation
Farré 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation
Pépin 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. Review. — View 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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2014;1:CD007736. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | CPAP efficacy: Apnea Hypopnea Index (AHI) | defined as Apnea Hypopnea Index (AHI) | 6 months | |
Other | Daytime somnolence | Epworth Sleepiness Scale (ESS) Score | 6 months | |
Other | Mask leakage | L/min | 6 months | |
Other | Adverse effects on CPAP | List of adverse effects | 6 months | |
Other | Overall Nocturnal Sleep quality | Pittsburgh Sleep Quality Index (PSQI) | 6 months | |
Primary | CPAP usage | defined as the proportion of night with CPAP usage =1h | 1 week | |
Primary | CPAP usage | defined as the proportion of night with CPAP usage =1h | 1 month | |
Primary | CPAP usage | defined as the proportion of night with CPAP usage =1h | 6 months | |
Primary | CPAP adherence | defined as the proportion of night with CPAP usage =4h | 1 week | |
Primary | CPAP adherence | defined as the proportion of night with CPAP usage =4h | 1 month | |
Primary | CPAP adherence | defined as the proportion of night with CPAP usage =4h | 6 months | |
Secondary | average nightly usage of CPAP | (hour/night) | 1 week | |
Secondary | average nightly usage of CPAP | (hour/night) | 1 month | |
Secondary | average nightly usage of CPAP | (hour/night) | 6 months |
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