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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-06-01

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.

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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.

Conditions

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Sleep Apnea, Obstructive OSA Sleep Sleep Disorder Hypersomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Telemedicine & Humidification

Intervention Type DEVICE

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telemedicine & Humidification

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No