Taltirelin in obstructive sleep apnea

Taltirelin for the treatment of obstructive sleep apnea, double-blind randomized, placebo-controlled, crossover study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031200308

Enrollment

Registered

2021-01-18

Start date

2021-04-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnea syndrome Obstructive sleep apnea

Interventions

Oral administration of taltirelin (7.5mg) or placebo 30 minutes before bedtime

taltirelin, placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
AHI scored using American Academy of Sleep Medicine(AASM)	—

Secondary

Measure	Time frame
-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	—

Contacts

Public ContactRyo Naito

Juntendo University

rnaitou@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026