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

Sleep Clinical Trial

— THINK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04300166
• Other study ID #: ongoing
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: March 2020
• Source: Neuromed IRCCS
• Contact: Andrea Romigi, PhD
• Phone: +390865929636
• Email: andrea.romigi[@]neuromed.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Hypersomnia
• OSA
• Sleep
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• Telemedicine & Humidification
Wireless control of CPAP usage, adherence, leakage and humidifier usage

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Andrea Romigi	Sleep Apnoea Italian Patient Association

References & Publications (11)

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

Outcome

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