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

NCT04300166 | Unknown FDA Device

• 1 other identifier: ongoing
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Apnea, Obstructive; OSA; Sleep; Sleep Disorder; Hypersomnia

Keywords

Telemedicine; CPAP

Outcome Measures

Primary Outcomes (6)

• CPAP usage

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

  1 week

• CPAP usage

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

  1 month

• CPAP usage

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

  6 months

• CPAP adherence

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

  1 week

• CPAP adherence

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

  1 month

• CPAP adherence

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

  6 months

Secondary Outcomes (3)

• average nightly usage of CPAP

  1 week

• average nightly usage of CPAP

  1 month

• average nightly usage of CPAP

  6 months

Other Outcomes (5)

• CPAP efficacy: Apnea Hypopnea Index (AHI)

  6 months

• Daytime somnolence

  6 months

• Mask leakage

  6 months

Study Arms (2)

Telemedicine & Humidification Intervention

ACTIVE COMPARATOR

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: 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.

Device: Telemedicine & Humidification

Control without Telemedicine & humidification

NO INTERVENTION

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

Interventions

Telemedicine & Humidification DEVICE

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

Telemedicine & Humidification Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrea Romigi: lead
• Sleep Apnoea Italian Patient Association: collaborator

Related Publications (11)

• 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.

  PMID: 24061345 BACKGROUND

• 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.

  PMID: 18625666 BACKGROUND

• 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.

  PMID: 19370691 BACKGROUND

• 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.

  PMID: 27018174 BACKGROUND

• 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.

  PMID: 28858567 BACKGROUND

• 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.

  PMID: 28926279 BACKGROUND

• 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.

  PMID: 29157591 BACKGROUND

• 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.

  PMID: 26253747 BACKGROUND

• 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.

  PMID: 28621155 BACKGROUND

• 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.

  PMID: 29024308 BACKGROUND

• 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.

  PMID: 31310575 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Wake Disorders; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Diego Centonze, PhD

  IRCCS Neuromed

  STUDY CHAIR

Central Study Contacts

Andrea Romigi, PhD

CONTACT

+390865929636; andrea.romigi@neuromed.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share