Insomnia DisorderPhase 2NCT03056053
Study to Validate the Questionnaire Called IDSIQ™ in Patients With Insomnia Disorder
A Phase 2 study testing Zolpidem in people with Insomnia Disorder, run by Idorsia Pharmaceuticals Ltd. at 9 sites in 2 countries.
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™). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 15 Feb 2017to 5 May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States5 sites
Neurotrials Research Inc
Atlanta, Georgia, 30342
CTI Clinical Research Center
Cincinnati, Ohio, 45255
Clinical Research CTR of Nevada
Las Vegas, Nevada, 89104
Clinilabs NYC
New York, New York, 10019
Santa Monica Clinical Trials
Santa Monica, California, 90404
Germany4 sites
St-Hedwig Krankenhaus, Schlaflab
Berlin, 10115
Advanced Sleep Research Berlin
Berlin, 10117
CTC North, Universitätsklinikum Hamburg- Eppendorf
Hamburg, 20251
Somnibene Inst Med Forschung & Schlafmedizin
Schwerin, 19053
About this study
Official title: 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™).
Read the 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.
- Conditions
- Insomnia Disorder
- Being tested
- Zolpidem
- Keywords
- insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolpidemDrug
Also called Ambien, Zolpidem generics, Stilnox
Commercially available tablets of zolpidem (5 or 10 mg) for oral use
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the screening period, i.e. within 14 days before Day 1
Secondary outcomes (3)
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
Measured: 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
Measured: 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)
Measured: At Week 1 and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start15 Feb 2017
- Primary completion21 Apr 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Mangialaio, MD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056053
- Sponsor's protocol ID
- AC-078A203
- Status last verified
- Jul 2019
- First submitted
- 31 Jan 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38302765Hudgens 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.
PubMed 33131027
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Single-arm, Open-label Study in Patients With Insomnia Disorder to Validate the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™)
- ClinicalTrials.gov ID
- NCT03056053
- Acronym / sponsor ID
- AC-078A203
- Conditions
- Insomnia Disorder
- Keywords
- insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zolpidem | Other | Drug: ZolpidemCommercially 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZolpidemAlso: Ambien, Zolpidem generics, StilnoxCommercially available tablets of zolpidem (5 or 10 mg) for oral use | Drug | Zolpidem |
Primary outcome
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
3 secondary outcomes
Psychometric validitiy of the IDSIQ™: Internal reliability
Time frame: During the screening period, i.e. within 14 days before Day 1
Psychometric validitiy of the IDSIQ™: Test-retest reliability
Time frame: During the screening period, i.e. within 14 days before Day 1
Psychometric validitiy of the IDSIQ™: sensitivity to change
Time frame: At Week 1 and Week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Derived from this study: PubMed 38302765Phillips-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.
- Derived from this study: PubMed 33131027Hudgens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Mangialaio, MD study director
Actelion
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zolpidem in people with Insomnia Disorder, run by Idorsia Pharmaceuticals Ltd. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content validity of the IDSIQ™: scoring of items into domains (time frame: During the screening period, i.e. within 14 days before Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03056053, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.