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

• ClinicalTrials.gov Identifier: NCT04300166
• Recruitment Status: Unknown
• First Posted: March 9, 2020
• Last Update Posted: March 9, 2020
• Sponsor: Andrea Romigi
• Collaborator: Sleep Apnoea Italian Patient Association
• Information provided by (Responsible Party): Andrea Romigi, Neuromed IRCCS

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea, Obstructive; OSA; Sleep; Sleep Disorder; Hypersomnia	Device: Telemedicine & Humidification	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Telemedicine and Humidification for Continous Positive Airway Pressure (CPAP) in OSAS.
• Estimated Study Start Date: June 1, 2020
• Estimated Primary Completion Date: June 1, 2021
• Estimated Study Completion Date: June 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Telemedicine & Humidification Intervention; In 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: CPAP usage <4h/ night for 3 consecutive night; 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.	Device: Telemedicine & Humidification; Wireless control of CPAP usage, adherence, leakage and humidifier usage
No Intervention: Control without Telemedicine & humidification; In 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

Outcome Measures

Primary Outcome Measures :

1. CPAP usage [ Time Frame: 1 week ]
   defined as the proportion of night with CPAP usage ≥1h
2. CPAP usage [ Time Frame: 1 month ]
   defined as the proportion of night with CPAP usage ≥1h
3. CPAP usage [ Time Frame: 6 months ]
   defined as the proportion of night with CPAP usage ≥1h
4. CPAP adherence [ Time Frame: 1 week ]
   defined as the proportion of night with CPAP usage ≥4h
5. CPAP adherence [ Time Frame: 1 month ]
   defined as the proportion of night with CPAP usage ≥4h
6. CPAP adherence [ Time Frame: 6 months ]
   defined as the proportion of night with CPAP usage ≥4h

Secondary Outcome Measures :

1. average nightly usage of CPAP [ Time Frame: 1 week ]
   (hour/night)
2. average nightly usage of CPAP [ Time Frame: 1 month ]
   (hour/night)
3. average nightly usage of CPAP [ Time Frame: 6 months ]
   (hour/night)

Other Outcome Measures:

1. CPAP efficacy: Apnea Hypopnea Index (AHI) [ Time Frame: 6 months ]
   defined as Apnea Hypopnea Index (AHI)
2. Daytime somnolence [ Time Frame: 6 months ]
   Epworth Sleepiness Scale (ESS) Score
3. Mask leakage [ Time Frame: 6 months ]
   L/min
4. Adverse effects on CPAP [ Time Frame: 6 months ]
   List of adverse effects
5. Overall Nocturnal Sleep quality [ Time Frame: 6 months ]
   Pittsburgh Sleep Quality Index (PSQI)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Andrea Romigi, PhD; +390865929636; andrea.romigi@neuromed.it

Sponsors and Collaborators

Andrea Romigi

Sleep Apnoea Italian Patient Association

Investigators

• Study Chair: Diego Centonze, PhD; IRCCS Neuromed

More Information

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: Andrea Romigi, MD PhD, Neuromed IRCCS
• ClinicalTrials.gov Identifier: NCT04300166
• Other Study ID Numbers: ongoing
• First Posted: March 9, 2020
• Last Update Posted: March 9, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Andrea Romigi, Neuromed IRCCS:

Telemedicine; CPAP

Additional relevant MeSH terms:

Sleep Apnea, Obstructive; Sleep Wake Disorders; Disorders of Excessive Somnolence; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Mental Disorders