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

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ClinicalTrials.gov Identifier: NCT03056053
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Tracking Information
First Submitted Date  ICMJE January 31, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE February 15, 2017
Actual Primary Completion Date April 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
Content validity of the IDSIQ™: scoring of items into domains [ Time Frame: During the screening period, i.e. within 14 days before Day 1 ]
Content validity will be based on the combination of qualitative and statistical methods in order to generate a scoring algorithm
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03056053 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Psychometric validitiy of the IDSIQ™: Internal reliability [ Time Frame: During the screening period, i.e. within 14 days before Day 1 ]
    Internal consistency reliability assesses the extent to which the items correlate which each other within their domain and it is evaluated by correlation scores
  • Psychometric validitiy of the IDSIQ™: Test-retest reliability [ Time Frame: During the screening period, i.e. within 14 days before Day 1 ]
    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
  • Psychometric validitiy of the IDSIQ™: sensitivity to change [ Time Frame: At Week 1 and Week 2 ]
    Changes in the IDSIQ domain scores after 2 weeks of treatment with zolpidem compared to baseline (before zolpidem administration)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Validate the Questionnaire Called IDSIQ™ in Patients With Insomnia Disorder
Official Title  ICMJE Multi-center, Single-arm, Open-label Study in Patients With Insomnia Disorder to Validate the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Insomnia Disorder
Intervention  ICMJE Drug: Zolpidem
Commercially available tablets of zolpidem (5 or 10 mg) for oral use
Other Names:
  • Ambien
  • Zolpidem generics
  • Stilnox
Study Arms  ICMJE 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
Intervention: Drug: Zolpidem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2017)
113
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
100
Actual Study Completion Date  ICMJE May 5, 2017
Actual Primary Completion Date April 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056053
Other Study ID Numbers  ICMJE AC-078A203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Idorsia Pharmaceuticals Ltd.
Study Sponsor  ICMJE Idorsia Pharmaceuticals Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sara Mangialaio, MD Actelion
PRS Account Idorsia Pharmaceuticals Ltd.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP