Comorbid insomnia and obstructive sleep apnea
Conditions
Interventions
Treatment group:daridorexant
Control group:placebo
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age =18 years, any gender; 2.Meet the diagnostic criteria for chronic insomnia and obstructive sleep apnea (OSA) specified in this study; 3.Insomnia Severity Index (ISI) score >10; 4.Absence of psychiatric or intellectual impairment, able to understand and finish scale assessments; 5.Provide written informed consent for study participation;
Exclusion criteria
Exclusion criteria: 1.PSG-derived nadir SpO22 time zones within 2 weeks before screening, or planned night shift work / >2 time zone travel during the study; presence of circadian sleep-wake rhythm disorders; 5.Use of classical benzodiazepines (estazolam, alprazolam, lorazepam, diazepam, oxazepam, clonazepam), psychostimulants, or muscle relaxants, from 2 weeks prior to screening or 5 half-lives (whichever is longer) until completion of safety follow-up; 6.Prior diagnosis of =1 psychiatric disorder: mania / manic episodes, schizophrenia, major depressive disorder with psychotic features, bipolar disorder, substance abuse, active major depressive episode or active major depressive episode within past 6 months, or unstable psychiatric illness; 7.Consumption of strong CYP3A4 inhibitors, strong CYP3A4 inducers, or grapefruit-containing beverages (including but not limited to ketoconazole, itraconazole, voriconazole, rifampicin, carbamazepine), from 2 weeks prior to screening or 5 half-lives (whichever is longer) until completion of safety follow-up; 8.Heavy smoking (=1 pack/day), or daily caffeine intake =600 mg; 9.Unstable, severe, or acute disease requiring hospitalization or surgery; or investigator-judged abnormalities within 1 month before screening that may compromise subject safety or interfere with study assessments; 10.Pregnancy or lactation; participation in another interventional clinical trial; 11.Subjects deemed unlikely to comply with the protocol or otherwise unsuitable for participation at the investigator’s discretion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Sleep Time (TST); | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep?related assessments via questionnaires and sleep diary;Nocturnal sleep and sleep?disordered?breathing parameters from PSG;Physiological endotype parameters of OSA;Treatment related safety outcomes;Metabolomic and immune?inflammatory molecular profiles;Daytime function, mood and cognitive performance; | — |
Countries
China
Contacts
Public ContactHuan Yu
Huashan Hospital, Fudan University
Outcome results
None listed