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

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ClinicalTrials.gov Identifier: NCT04300166
Recruitment Status : Unknown
Verified March 2020 by Andrea Romigi, Neuromed IRCCS.
Recruitment status was:  Not yet recruiting
First Posted : March 9, 2020
Last Update Posted : March 9, 2020
Sleep Apnoea Italian Patient Association
Information provided by (Responsible Party):
Andrea Romigi, Neuromed IRCCS

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

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:

  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
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

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 ]

  2. average nightly usage of CPAP [ Time Frame: 1 month ]

  3. average nightly usage of CPAP [ Time Frame: 6 months ]

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 ]

  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)

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300166

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

Sponsors and Collaborators
Andrea Romigi
Sleep Apnoea Italian Patient Association
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Study Chair: Diego Centonze, PhD IRCCS Neuromed

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Responsible Party: Andrea Romigi, MD PhD, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT04300166    
Other Study ID Numbers: ongoing
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Wake Disorders
Disorders of Excessive Somnolence
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Nervous System Diseases
Neurologic Manifestations
Mental Disorders