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

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

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

Study Overview

• Status: Completed
• Conditions: Insomnia Disorder
• Intervention / Treatment: Drug: Zolpidem

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10115
    • St-Hedwig Krankenhaus, Schlaflab
  • Berlin, Germany, 10117
    • Advanced Sleep Research Berlin
  • Hamburg, Germany, 20251
    • CTC North, Universitätsklinikum Hamburg- Eppendorf
  • Schwerin, Germany, 19053
    • Somnibene Inst Med Forschung & Schlafmedizin
• United States
  • California
    • Santa Monica, California, United States, 90404
      • Santa Monica Clinical Trials
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research Inc
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Clinical Research CTR of Nevada
  • New York
    • New York, New York, United States, 10019
      • Clinilabs NYC
  • Ohio
    • Cincinnati, Ohio, United States, 45255
      • CTI Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Zolpidem; Commercially available zolpidem (5 or 10 mg) will be administered orally once daily during the treatment period (Day 1 to Day 14) following prescribing information from each country participating in this study	Drug: Zolpidem; Commercially available tablets of zolpidem (5 or 10 mg) for oral use; Other Names: Ambien; Zolpidem generics; Stilnox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.
• Investigators: Study Director: Sara Mangialaio, MD, Actelion

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): April 21, 2017
• Study Completion (Actual): May 5, 2017

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: AC-078A203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No