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

NCT03056053 | Completed Phase 2

• 1 other identifier: AC-078A203
• Study Type: interventional
• Target: 113
• Locations: 2 countries
• Sites: 9

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™).

Conditions

Insomnia Disorder

Keywords

insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Psychometric validitiy of the IDSIQ™: Internal reliability

  During the screening period, i.e. within 14 days before Day 1

• Psychometric validitiy of the IDSIQ™: Test-retest reliability

  During the screening period, i.e. within 14 days before Day 1

• Psychometric validitiy of the IDSIQ™: sensitivity to change

  At Week 1 and Week 2

Study Arms (1)

Zolpidem

OTHER

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

Interventions

Zolpidem DRUG

Commercially available tablets of zolpidem (5 or 10 mg) for oral use

Also known as: Ambien, Zolpidem generics, Stilnox

Zolpidem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (9)

Santa Monica Clinical Trials

Santa Monica, California, 90404, United States

Location

Neurotrials Research Inc

Atlanta, Georgia, 30342, United States

Location

Clinical Research CTR of Nevada

Las Vegas, Nevada, 89104, United States

Location

Clinilabs NYC

New York, New York, 10019, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45255, United States

Location

St-Hedwig Krankenhaus, Schlaflab

Berlin, 10115, Germany

Location

Advanced Sleep Research Berlin

Berlin, 10117, Germany

Location

CTC North, Universitätsklinikum Hamburg- Eppendorf

Hamburg, 20251, Germany

Location

Somnibene Inst Med Forschung & Schlafmedizin

Schwerin, 19053, Germany

Location

Related Publications (2)

• Phillips-Beyer A, Kawata AK, Kleinman L, Seboek Kinter D, Flamion B. Meaningful Within-Patient Change in Subjective Total Sleep Time in Patients with Insomnia Disorder: An Analysis of the Sleep Diary Questionnaire Using Data from Open-Label and Phase III Clinical Trials. Pharmaceut Med. 2024 Mar;38(2):133-144. doi: 10.1007/s40290-023-00512-9. Epub 2024 Feb 1.

  PMID: 38302765 DERIVED

• 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.

  PMID: 33131027 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sara Mangialaio, MD

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 17, 2017
• Study Start: February 15, 2017
• Primary Completion: April 21, 2017
• Study Completion: May 5, 2017
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

DE (4); US (5)