Taltirelin in obstructive sleep apnea

JRCT ID: jRCTs031200308

Registered date:18/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Obstructive sleep apnea syndrome
• Date of first enrollment: 06/04/2021
• Target sample size: 13
• Study type: Interventional
• Intervention(s): Oral administration of taltirelin (7.5mg) or placebo 30 minutes before bedtime

Outcome(s)

• Primary Outcome: AHI scored using American Academy of Sleep Medicine(AASM)

Secondary Outcome

-AHI using alternative definition of hypopneas (4% SaO2 desaturation and 30% reduction in flow)
-Hypoxic Burden (desaturation area under curve * event frequency)
-Arousal index (number of arousals / hours of sleep)
-Sleep efficiency (total sleep time / time in bed)
-Visual analog scale for sleep quality
-Karolinska Sleepiness Scale
-Epworth Sleepiness Scale

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

-Ages 20-70 years
-Diagnosed moderate to severe OSA (AHI between 15 and 60)
-Majority of events are hypopneas (fraction of hypopneas >50%)
-Mean oxygen desaturation associated with respiratory events is <8%
-Written informed consent provided
*PSG will be performed before enrollment if data on PSG within 3 months of enrollment are not available.

Exclude criteria

-Any uncontrolled medical condition
-Current use of the medications under investigation
-Use of medications expected to stimulate or depress respiration including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid
-Conditions likely to affect obstructive sleep apnea physiology (neuromuscular disease or other major neurological disorder, heart failure, or any other unstable major medical condition)
-Respiratory disorders other than sleep disordered breathing (chronic hypoventilation / hypoxemia (awake SaO2 <92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions)
-Other sleep disorders (periodic limb movements, narcolepsy, or parasomnias)
-Hypersensitivity to taltirelin
-Dysthyroidism
-History of renal disease
-Pregnancy or nursing
-Lack of written informed consent

Related Information

• Primary Sponsor: Kasai Takatoshi
• Source(s) of Monetary Support: Apnimed, Inc