Obstructive Sleep Apnea (OSA) is the most common and serious of the sleep disorders. Long-term, OSA is associated with increased morbidity and mortality, with a number of adverse cardiovascular, neurocognitive, metabolic, and daytime functioning consequences. No drugs are currently approved for OSA treatment. This is a randomized, double blind, placebo controlled, cross-over, inpatient phase 2 clinical trial to examine the efficacy and the safety of a fixed dose level of AD128 in patients with OSA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Istituto Auxologico Italiano,Ospedale San Luca
Milan, Italy
Change in Apnea-Hypopnea Index (AHI)
The percentage change of mean AHI will be compared between treatment groups.
Time frame: From the screening/baseline to the last day of treatment (7 days after the start of each treatment period).
AHI decrease ≥50%
The proportion of patients with AHI decrease ≥50% will be calculated.
Time frame: From screening/baseline to the last day of treatment (7 days after the start of each treatment period).
AHI<15/hour
The number of patients with AHI \<15/hour measured during the inpatient night Polysomnography will be compared between treatment groups.
Time frame: From screening/baseline to the last day of treatment (7 days after the start of each treatment period).
Change in Epworth Sleepiness Scale (ESS)
The ESS is a self-administered questionnaire which measures the daytime sleepiness. The ESS score can range from 0 to 24. The change will be measured in terms of difference from baseline and between treatment groups.
Time frame: From screening/baseline to the last day of treatment (7 days after the start of each treatment period).
Change in Karolinska Sleepiness Scale (KSS)
The KSS is a self-reported 9-points scale which measure the subjective level of sleepiness at a particular time during the day. The change will be measured in terms of difference from baseline and between treatment groups.
Time frame: From screening/baseline to the last day of treatment (7 days after the start of each treatment period).
Patient Global Impression of OSA Severity (PGI-S)
The PGI-S is a single question asking the patient to rate on a scale, ranging from 0 to 4, the severity of the OSA condition at that time.
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Time frame: From screening/baseline to the last day of treatment (7 days after the start of each treatment period).
Change in Psychomotor Vigilance Test (PVT)
PVT is a chronometric measure of a patient's reaction time to a visual stimulus. PVT reaction times/lapses and failures to react will be measured. The change will be measured in terms of difference from baseline and between treatment groups.
Time frame: From screening/baseline to last day of treatment (7 days after the start of each treatment period).
Change in Oxygen Desaturation Index (ODI) 3%
The number of times per hour of sleep that the blood's oxygen level drops by 3% from baseline will be measured by means of a CE marked oximeter capable of nightly recording and storage of data for the entire at-home period. The change in mean value from baseline will be compared between treatment groups.
Time frame: From screening/baseline to last day of treatment (7 days after the start of each treatment period).
Change in total time with Oxygen Saturation (SaO2) <90%
Time frame: From screening/baseline to last day of treatment (7 days after the start of each treatment period).
Change in mean SaO2
Time frame: From screening/baseline to last day of treatment (7 days after the start of each treatment period).
Change in minimum SaO2
Time frame: From screening/baseline to last day of treatment (7 days after the start of each treatment period).
Change in arousal index
The number of arousals will be registered during the polysomnography and reported as a frequency per hour of sleep. The change in mean value from baseline will be compared between treatment groups.
Time frame: From screening/baseline to last day of treatment (7 days after the start of each treatment period).
Change in periodic limb movement
The number of periodic limb movements will be measured during the polysomnography. The change in mean value from baseline will be compared between treatment groups.
Time frame: From screening/baseline to last day of treatment (7 days after the start of each treatment period).
Oxygen Desaturation Index 4%
The number of times per hour of sleep that the blood's oxygen level drops by 4% or more from baseline will be measured by means of a CE marked oximeter capable of nightly recording and storage of data. The average numbers will be compared between treatment groups.
Time frame: For the entire at home treatment period: days 1-7 (before crossover) and days 15-20 (after crossover)
Adverse Events (AE)
All adverse events occurring to patients after recruitment in the study will be recorded. The total number of AEs, their severity and their seriousness will be compared between treatment groups.
Time frame: From screening/baseline to 4 weeks after last day of treatment.