Study to validate the questionnaire called IDSIQ™ in patients suffering from difficulties to sleep.

Multi-center, single-arm, open-label study in patients with Insomnia Disorder to validate the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004259-59-DE

Enrollment

100

Registered

2016-11-30

Start date

2017-01-31

Completion date

Unknown

Last updated

2018-11-26

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

Conditions

Insomnia disorder MedDRA version: 20.0 Level: PT Classification code 10022437 Term: Insomnia System Organ Class: 10037175 - Psychiatric disorders

Interventions

Pharmaceutical Form: Film-coated tablet INN or Proposed INN: zolpidem tartrate CAS Number: 99294-93-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent prior to any study-mandated procedure; - Male or female aged = 18 years; - Body mass index (BMI): 18.5 = BMI (kg/m2) =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement behavior disorder, or narcolepsy; - Self-reported usual daytime napping = 1 hour per day, and = 3 days per week; - Caffeine consumption = 600 mg per day; - Shift work within 2 weeks prior to the screening visit, or planned shift work from V1 to V3; - Travel = 3 time zones within 1 week prior to the screening visit, or planned travel = 3 time zones from V1 to V3; - Known severe renal impairment or know moderate or severe hepatic impairment; - History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments; - Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main study objective is to assess the content validity and the psychometric characteristics of the IDSIQ™ and evaluate its appropriateness for use in the population of patients with insomnia disorder. ;Secondary Objective: To assess the effect of zolpidem on changes in the IDSIQ™ domain scores from baseline to week 1 and week 2. ;Primary end point(s): The main endpoints are the items of the IDSIQ™ which will be combined into domain scores based on the to-be-developed scoring algorithm;Timepoint(s) of evaluation of this end point: From screening to end of treatment (EOT)	—

Measure

Time frame

Main Objective: The main study objective is to assess the content validity and the psychometric characteristics of the IDSIQ™ and evaluate its appropriateness for use in the population of patients with insomnia disorder. ;Secondary Objective: To assess the effect of zolpidem on changes in the IDSIQ™ domain scores from baseline to week 1 and week 2. ;Primary end point(s): The main endpoints are the items of the IDSIQ™ which will be combined into domain scores based on the to-be-developed scoring algorithm;Timepoint(s) of evaluation of this end point: From screening to end of treatment (EOT)

—

Secondary

Measure	Time frame
Secondary end point(s): Changes from baseline to week 1 and to week 2 in the IDSIQ™ domain scores ;Timepoint(s) of evaluation of this end point: From baseline to week 1 and week 2	—

Countries

Germany, United States

Contacts

Public ContactClinical Trial Disclosure Desk

Idorsia Pharmaceuticals Ltd

clinical-trials-disclosure@idorsia.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026