Insomnia, NonorganicNCT03114696
Benefit of IQP-AO-101 for Sleep
A study testing IQP-AO-101 in people with Insomnia, Nonorganic, run by InQpharm Group at 1 site in Germany.
Trial summary
The objective of this pilot clinical trial is to evaluate the potential of IQP-AO-101 with respect to sleep-promoting effects in subjects with sleep complaints. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Nonorganic
- What is being tested?
- IQP-AO-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 25 Apr 2017to 29 Sep 2017
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21-65 years old
- Non-organic moderate sleep complaints in the last year prior to V1, as per investigator's judgement
- Pittsburgh Sleep Quality Index (PSQI) score 6-15 at V1
- Body mass index (BMI) 18.5-29.9 kg/m2
- Generally in good health without clinically significant findings at V1
- Readiness to comply with study procedures, in particular:
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- Consumption of the IP during the treatment period
- Wearing activity tracker during the scheduled time periods
- Filling in the subject diary
- Keeping habitual diet and level of physical exercise, as well as smoking habits if applicable
- Women of child-bearing potential:
- Negative pregnancy testing (ß-HCG in urine) at V1
- Commitment to use reliable contraception methods during the entire study
- Written informed consent form
Who cannot join
- Known sensitivity to any components of the investigational product
- Insomnia (according to investigator's judgement))
- Substantial daily sleepiness as per investigator's judgement
- Less than 5 hours sleep per night on average, self-reported at V1
- Any medical condition associated with sleep disorder as per investigator's judgement (e.g. sleep apnoea, restless legs syndrome, neurological / psychiatric disorder)
- Any lifestyle and other factors potentially associated with sleep problems as per investigator's judgement (e.g. excessive caffeine intake, shift work, long-distance travelling, significant stressors such as active grieving etc.)
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- History and/or presence of clinically significant dis-ease, which per investigator's judgement could interfere with the results of the study or the safety of the subject:
- Eating disorders such as anorexia
- Untreated or non-stabilised metabolic diseases, e.g. diabetes mellitus
- Untreated or non-stabilised thyroid disorder
- Untreated or non-stabilised hypertension (regular systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg)
- Significant gastrointestinal diseases
- Any other known significant or serious condition / disease that renders subjects ineligible (e.g. history of malignancy within the past 5 years prior to V1, any clinically significant cardiovascular, renal, liver disease etc.)
- Use of drugs/supplements which could interfere with the results of the study as per investigator's judgement (e.g. melatonin and melatonin derivatives, stimulants, neuroleptics, benzodiazepines, antidepressants, hypnotics) within the last 4 weeks prior to V1 and during the study
- Behavioural intervention for sleep difficulties in the past 6 months and during the study as per investigator's judgement
- Deviation of laboratory parameter(s) at V1 that is:
- clinically significant or
- >2x ULN (upper limit of normal), unless the deviation is justified by a previously known not clinically relevant condition, e.g. Gilbert's syndrome)
- Alcohol abuse (men: ≥21 units/week, women: ≥14 units/ week; 1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
- Drug abuse
- Participation in another study during the last 4 weeks prior to V1 and during the study
- Women of child-bearing potential: pregnant or breast-feeding
- Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo-controlled, Randomised Pilot Clinical Trial to Explore Benefit and Tolerability of IQP-AO-101 in Healthy Subjects With Sleep Complaints
The objective of this pilot clinical trial is to evaluate the potential of IQP-AO-101 with respect to sleep-promoting effects in subjects with sleep complaints.
- Conditions
- Insomnia, Nonorganic
- Being tested
- IQP-AO-101, Placebo
- 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.
IQP-AO-101Dietary supplement
1 dose (sachet) to be consumed 30 - 60 mins before bedtime
PlaceboDietary supplement
1 dose to be consumed 30 - 60 mins before bedtime. (Identical to investigational product)
| Study group | Role | What they receive |
|---|---|---|
| IQP-AO-101 | Experimental | 1 dose (sachet) to be consumed 30 - 60 mins before bedtime Receives: Dietary Supplement: IQP-AO-101 |
| Placebo | Placebo comparator | 1 dose (sachet) to be consumed 30 - 60 mins before bedtime Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mAIS parameters at V5 vs V2
Change in modified Athens Insomnia Scale parameters
Measured: 6 weeks
Secondary outcomes (3)
Change in mAIS parameter at V3 and V4, vs V2
Change in modified Athens Insomnia Scale parameters
Measured: 1 week, 4 weeks
Change in activity tracker sleep parameters
Use of an activity tracker to monitor sleep and compare against baseline
Measured: 1 week, 6 weeks
Change in FAIR-2
Change in FAIR-2 at each visit
Measured: 1 week, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start25 Apr 2017
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia, NonorganicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114696
- Sponsor's protocol ID
- INQ/020316
- Status last verified
- Jan 2018
- First submitted
- 6 Apr 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bongartz U, Tan BK, Seibt S, Bothe G, Uebelhack R, Chong PW, Wszelaki N. Sleep Promoting Effects of IQP-AO-101: A Double-Blind, Randomized, Placebo-Controlled Exploratory Trial. Evid Based Complement Alternat Med. 2019 May 2;2019:9178218. doi: 10.1155/2019/9178218. eCollection 2019.
PubMed 31186669
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomised Pilot Clinical Trial to Explore Benefit and Tolerability of IQP-AO-101 in Healthy Subjects With Sleep Complaints
- ClinicalTrials.gov ID
- NCT03114696
- Acronym / sponsor ID
- INQ/020316
- Conditions
- Insomnia, Nonorganic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 14 Apr 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 objective of this pilot clinical trial is to evaluate the potential of IQP-AO-101 with respect to sleep-promoting effects in subjects with sleep complaints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IQP-AO-101 | Experimental | Dietary Supplement: IQP-AO-1011 dose (sachet) to be consumed 30 - 60 mins before bedtime |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 dose (sachet) to be consumed 30 - 60 mins before bedtime |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 21-65 years old
- Non-organic moderate sleep complaints in the last year prior to V1, as per investigator's judgement
- Pittsburgh Sleep Quality Index (PSQI) score 6-15 at V1
- Body mass index (BMI) 18.5-29.9 kg/m2
- Generally in good health without clinically significant findings at V1
Key exclusion criteria (23 listed)
- Known sensitivity to any components of the investigational product
- Insomnia (according to investigator's judgement))
- Substantial daily sleepiness as per investigator's judgement
- Less than 5 hours sleep per night on average, self-reported at V1
- Any medical condition associated with sleep disorder as per investigator's judgement (e.g. sleep apnoea, restless legs syndrome, neurological / psychiatric disorder)
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 |
|---|---|---|
| IQP-AO-1011 dose (sachet) to be consumed 30 - 60 mins before bedtime | Dietary supplement | IQP-AO-101 |
| Placebo1 dose to be consumed 30 - 60 mins before bedtime. (Identical to investigational product) | Dietary supplement | Placebo |
Primary outcome
Change in mAIS parameters at V5 vs V2
Time frame: 6 weeks
Change in modified Athens Insomnia Scale parameters
3 secondary outcomes
Change in mAIS parameter at V3 and V4, vs V2
Time frame: 1 week, 4 weeks
Change in activity tracker sleep parameters
Time frame: 1 week, 6 weeks
Change in FAIR-2
Time frame: 1 week, 4 weeks, 6 weeks
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 3 Jan 2018.
- Derived from this study: PubMed 31186669Bongartz U, Tan BK, Seibt S, Bothe G, Uebelhack R, Chong PW, Wszelaki N. Sleep Promoting Effects of IQP-AO-101: A Double-Blind, Randomized, Placebo-Controlled Exploratory Trial. Evid Based Complement Alternat Med. 2019 May 2;2019:9178218. doi: 10.1155/2019/9178218. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IQP-AO-101 in people with Insomnia, Nonorganic, run by InQpharm Group at 1 site in Germany.
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 14 inclusion and 23 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 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in mAIS parameters at V5 vs V2 (time frame: 6 weeks). 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 NCT03114696, which also lists 1 linked publication.
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 3 Jan 2018.