Insomnia characterized by difficulty returning to sleep following a nocturnal awakening, otherwise called middle-of-the-night (MONT) insomnia MedDRA version: 14.1 Level: LLT Classification code 10029448 Term: Nocturnal awakening System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Songar 0,375 mg/ml gocce orali, soluzione
Pharmaceutical Form: Oral drops, solution
Sponsors
Valeas SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Night-time awakening (>= 5 nights/week) followed by a difficult to fall asleep in men or female aged over 18 years. - Latency to sleep after the night-time awakening: > 45 minutes - No difficult to fall asleep at the evening (Sleep Latency =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: - obstructive sleep apnoea syndrome (OSA), - restless leg syndrome - shift worker - any pathology influncing the sleep - psychiatric disorder according to ASSE 1 – DSM IV-TR - known hyperseitivity to triazolam - use of any central nervous system medication or other medications known to affect the sleep/wake function (washout at least of 7 days)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of different triazolam dosage in patients affected by difficulty returning to sleep following a nocturnal awakening;Secondary Objective: To evaluate the next morning residual effects of triazolam;Primary end point(s): To evaluate the efficacy of different triazolam dosage;Timepoint(s) of evaluation of this end point: Each morning. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the next morning residual effects of triazolam;Timepoint(s) of evaluation of this end point: each morning and every week with the vigilance tests | — |
Countries
Italy
Contacts
Public ContactMedical Direction
Valeas SpA
Outcome results
None listed