Back to resultsTelemedicine and Humidification for Cpap IN Osas Key Treatment (THINK Study) (THINK)
Primary Purpose
Sleep Apnea, Obstructive, OSA, Sleep
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telemedicine & Humidification
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Telemedicine, CPAP
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Telemedicine & Humidification Intervention
Control without Telemedicine & humidification
Arm Description
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.
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
Outcomes
Primary Outcome Measures
CPAP usage
defined as the proportion of night with CPAP usage ≥1h
CPAP usage
defined as the proportion of night with CPAP usage ≥1h
CPAP usage
defined as the proportion of night with CPAP usage ≥1h
CPAP adherence
defined as the proportion of night with CPAP usage ≥4h
CPAP adherence
defined as the proportion of night with CPAP usage ≥4h
CPAP adherence
defined as the proportion of night with CPAP usage ≥4h
Secondary Outcome Measures
average nightly usage of CPAP
(hour/night)
average nightly usage of CPAP
(hour/night)
average nightly usage of CPAP
(hour/night)
Full Information
NCT ID
NCT04300166
First Posted
March 5, 2020
Last Updated
March 6, 2020
Sponsor
Andrea Romigi
Collaborators
Sleep Apnoea Italian Patient Association
1. Study Identification
Unique Protocol Identification Number
NCT04300166
Brief Title
Telemedicine and Humidification for Cpap IN Osas Key Treatment (THINK Study)
Acronym
THINK
Official Title
Effects of Telemedicine and Humidification for Continous Positive Airway Pressure (CPAP) in OSAS.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrea Romigi
Collaborators
Sleep Apnoea Italian Patient Association
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, OSA, Sleep, Sleep Disorder, Hypersomnia
Keywords
Telemedicine, CPAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine & Humidification Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control without Telemedicine & humidification
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Telemedicine & Humidification
Intervention Description
Wireless control of CPAP usage, adherence, leakage and humidifier usage
Primary Outcome Measure Information:
Title
CPAP usage
Description
defined as the proportion of night with CPAP usage ≥1h
Time Frame
1 week
Title
CPAP usage
Description
defined as the proportion of night with CPAP usage ≥1h
Time Frame
1 month
Title
CPAP usage
Description
defined as the proportion of night with CPAP usage ≥1h
Time Frame
6 months
Title
CPAP adherence
Description
defined as the proportion of night with CPAP usage ≥4h
Time Frame
1 week
Title
CPAP adherence
Description
defined as the proportion of night with CPAP usage ≥4h
Time Frame
1 month
Title
CPAP adherence
Description
defined as the proportion of night with CPAP usage ≥4h
Time Frame
6 months
Secondary Outcome Measure Information:
Title
average nightly usage of CPAP
Description
(hour/night)
Time Frame
1 week
Title
average nightly usage of CPAP
Description
(hour/night)
Time Frame
1 month
Title
average nightly usage of CPAP
Description
(hour/night)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
CPAP efficacy: Apnea Hypopnea Index (AHI)
Description
defined as Apnea Hypopnea Index (AHI)
Time Frame
6 months
Title
Daytime somnolence
Description
Epworth Sleepiness Scale (ESS) Score
Time Frame
6 months
Title
Mask leakage
Description
L/min
Time Frame
6 months
Title
Adverse effects on CPAP
Description
List of adverse effects
Time Frame
6 months
Title
Overall Nocturnal Sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Romigi, PhD
Phone
+390865929636
Email
andrea.romigi@neuromed.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Centonze, PhD
Organizational Affiliation
IRCCS Neuromed
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24061345
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.
Results Reference
background
PubMed Identifier
18625666
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.
Results Reference
background
PubMed Identifier
19370691
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.
Results Reference
background
PubMed Identifier
27018174
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.
Results Reference
background
PubMed Identifier
28858567
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.
Results Reference
background
PubMed Identifier
28926279
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.
Results Reference
background
PubMed Identifier
29157591
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.
Results Reference
background
PubMed Identifier
26253747
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.
Results Reference
background
PubMed Identifier
28621155
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.
Results Reference
background
PubMed Identifier
29024308
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.
Results Reference
background
PubMed Identifier
31310575
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.
Results Reference
background
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Telemedicine and Humidification for Cpap IN Osas Key Treatment (THINK Study)
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