Study to Validate the Questionnaire Called IDSIQ™ in Patients With Insomnia Disorder

Insomnia Disorder Clinical Trial

Official title:

Multi-center, Single-arm, Open-label Study in Patients With Insomnia Disorder to Validate the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056053
• Other study ID #: AC-078A203
• Status: Completed
• Phase: Phase 2
• Start date: February 15, 2017
• Est. completion date: May 5, 2017

Study information

• Verified date: July 2019
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 5, 2017
• Est. primary completion date: April 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Zolpidem
Commercially available tablets of zolpidem (5 or 10 mg) for oral use

Locations

Country	Name	City	State
Germany	Advanced Sleep Research Berlin	Berlin
Germany	St-Hedwig Krankenhaus, Schlaflab	Berlin
Germany	CTC North, Universitätsklinikum Hamburg- Eppendorf	Hamburg
Germany	Somnibene Inst Med Forschung & Schlafmedizin	Schwerin
United States	Neurotrials Research Inc	Atlanta	Georgia
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Clinical Research CTR of Nevada	Las Vegas	Nevada
United States	Clinilabs NYC	New York	New York
United States	Santa Monica Clinical Trials	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Content validity of the IDSIQ™: scoring of items into domains	Content validity will be based on the combination of qualitative and statistical methods in order to generate a scoring algorithm	During the screening period, i.e. within 14 days before Day 1
Secondary	Psychometric validitiy of the IDSIQ™: Internal reliability	Internal consistency reliability assesses the extent to which the items correlate which each other within their domain and it is evaluated by correlation scores	During the screening period, i.e. within 14 days before Day 1
Secondary	Psychometric validitiy of the IDSIQ™: Test-retest reliability	Test-retest reliability assesses the reproducibility of the domain scores during a specific time period of stable condition and it is evaluated by intraclass correlation coefficients	During the screening period, i.e. within 14 days before Day 1
Secondary	Psychometric validitiy of the IDSIQ™: sensitivity to change	Changes in the IDSIQ domain scores after 2 weeks of treatment with zolpidem compared to baseline (before zolpidem administration)	At Week 1 and Week 2