Hypersomnia, OSA, Sleep, Sleep Apnea, Obstructive, Sleep Disorder
Conditions
Keywords
Telemedicine, CPAP
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.
Interventions
DEVICETelemedicine & Humidification
Wireless control of CPAP usage, adherence, leakage and humidifier usage
Sponsors
Sleep Apnoea Italian Patient Association
Andrea Romigi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP usage | 1 week | defined as the proportion of night with CPAP usage ≥1h |
| CPAP adherence | 1 week | defined as the proportion of night with CPAP usage ≥4h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| average nightly usage of CPAP | 1 week | (hour/night) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Daytime somnolence | 6 months | Epworth Sleepiness Scale (ESS) Score |
| Mask leakage | 6 months | L/min |
| Overall Nocturnal Sleep quality | 6 months | Pittsburgh Sleep Quality Index (PSQI) |
| Adverse effects on CPAP | 6 months | List of adverse effects |
| CPAP efficacy: Apnea Hypopnea Index (AHI) | 6 months | defined as Apnea Hypopnea Index (AHI) |
Contacts
Primary ContactAndrea Romigi, PhD
Outcome results
None listed