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

Not Applicable

• Conditions: OSA; Hypersomnia; Sleep Apnea, Obstructive; Sleep; Sleep Disorder
• Interventions: Device: Telemedicine & Humidification

• Registration Number: NCT04300166
• Lead Sponsor: Andrea Romigi

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-06
• Last Update Submitted: 2020-03-06
• Study First Posted: 2020-03-09
• Last Update Posted: 2020-03-09
• Study Start: 2020-06-01
• Primary Completion: 2021-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine & Humidification Intervention	Telemedicine & Humidification	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.

Primary Outcome Measures

Name	Time	Method
CPAP usage	6 months	defined as the proportion of night with CPAP usage ≥1h
CPAP adherence	6 months	defined as the proportion of night with CPAP usage ≥4h

Secondary Outcome Measures

Name	Time	Method
average nightly usage of CPAP	6 months	(hour/night)