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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Apnea, Obstructive, OSA, Sleep, Sleep Disorder, Hypersomnia

Intervention / Treatment
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* Device: Telemedicine & Humidification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telemedicine & Humidification Intervention<br>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<br>* Wireless control of CPAP usage, adherence, leakage and humidifier usage<br>|
| No Intervention: Control without Telemedicine & humidification<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average nightly usage of CPAP | (hour/night) | 1 week | 
| average nightly usage of CPAP | (hour/night) | 1 month | 
| average nightly usage of CPAP | (hour/night) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, CPAP