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The main study objective is to assess the content validity and the psychometric characteristics of the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zolpidem | Drug | Commercially available tablets of zolpidem (5 or 10 mg) for oral use |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Mangialaio, MD | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Monica Clinical Trials | Santa Monica | California | 90404 | United States | ||
| Neurotrials Research Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38302765 | Derived | 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. | |
| 33131027 |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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 |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Clinical Research CTR of Nevada | Las Vegas | Nevada | 89104 | United States |
| Clinilabs NYC | New York | New York | 10019 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45255 | United States |
| St-Hedwig Krankenhaus, Schlaflab | Berlin | 10115 | Germany |
| Advanced Sleep Research Berlin | Berlin | 10117 | Germany |
| CTC North, Universitätsklinikum Hamburg- Eppendorf | Hamburg | 20251 | Germany |
| Somnibene Inst Med Forschung & Schlafmedizin | Schwerin | 19053 | Germany |
| 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. |
| D001523 |
| Mental Disorders |