Evaluation in patients with sleeping disturbances using different dosages of triazolam

Conditions: Insomnia characterized by difficulty returning to sleep following a nocturnal awakening, otherwise called middle-of-the-night (MONT) insomnia
MedDRA version: 14.1Level: LLTClassification code 10029448Term: Nocturnal awakeningSystem Organ Class: 100000004873
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2013-000078-30-IT

Lead Sponsor: Valeas SpA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 < 30 minutes)
- Moderate use of alcool (max 2 glasses of wine/day), caffeine (not after 5 pm and max 2 cups/day) e nicotine (max 10 cigarettes/day)
- No pregnancy, if woman
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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