Clinical trial NCT03056053: Study to Validate the Questionnaire Called IDSIQ™ in Patients With Insomnia Disorder
Official title: Multi-center, Single-arm, Open-label Study in Patients With Insomnia Disorder to Validate the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia Disorder
Keywords: insomnia
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-17
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main study objective is to assess the content validity and the psychometric characteristics of the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™).

Detailed description: Zolpidem will be used as an active intervention to assess the sensitivity to change of IDSIQ™ in patients suffering from insomnia disorder.

IDSIQ™ will be administered during the screening period (within 14 days before enrollment in the study) and the treatment period (from Day 1 to Day 14). End of study (phone call) will take place 30-37 days after the end-of-treatment.

Eligibility 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) \< 32.0;
* Insomnia disorder according to DSM-5 criteria;
* Insufficient sleep quantity evaluated according to the self-reported history and data collected in the sleep diary;
* Insomnia Severity Index score greater than or equal to 15;
* Complete the IDSIQ™ and the sleep diary questionnaire as required.

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.

Primary outcomes:
measure: Content validity of the IDSIQ™: scoring of items into domains
timeFrame: During the screening period, i.e. within 14 days before Day 1
Secondary outcomes:
measure: Psychometric validitiy of the IDSIQ™: Internal reliability
timeFrame: During the screening period, i.e. within 14 days before Day 1
measure: Psychometric validitiy of the IDSIQ™: Test-retest reliability
timeFrame: During the screening period, i.e. within 14 days before Day 1
measure: Psychometric validitiy of the IDSIQ™: sensitivity to change
timeFrame: At Week 1 and Week 2
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Santa Monica Clinical Trials
state: California
city: Atlanta
country: United States
facility: Neurotrials Research Inc
state: Georgia
city: Las Vegas
country: United States
facility: Clinical Research CTR of Nevada
state: Nevada
city: New York
country: United States
facility: Clinilabs NYC
state: New York
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Berlin
country: Germany
facility: St-Hedwig Krankenhaus, Schlaflab
city: Berlin
country: Germany
facility: Advanced Sleep Research Berlin
city: Hamburg
country: Germany
facility: CTC North, Universitätsklinikum Hamburg- Eppendorf
city: Schwerin
country: Germany
facility: Somnibene Inst Med Forschung & Schlafmedizin
Study officials:
affiliation: Actelion
name: Sara Mangialaio, MD
role: STUDY_DIRECTOR
References:
citation: Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021 Mar;14(2):249-268. doi: 10.1007/s40271-020-00474-z. Epub 2020 Nov 1.