NCT04300166

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Andrea Romigi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea, Obstructive
• OSA
• Sleep
• Sleep Disorder
• Hypersomnia

Interventions

Type	Name	Description
DEVICE	Telemedicine & Humidification	Wireless control of CPAP usage, adherence, leakage and humidifier usage

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-06-01
• Completion: 2022-06-01
• First posted: 2020-03-09
• Last updated: 2020-03-09

Regulatory

• FDA-regulated device study