CompletedNot Applicable

Benefit of IQP-AO-101 for Sleep

Germany50 participantsStarted 2017-04-25

Plain-language 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.

Who can participate

Age range21 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. Women of child-bearing potential:
✓. Written informed consent form

Exclusion criteria

✕. 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.)
✕. 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:
✕. 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

What they're measuring

Change in mAIS parameters at V5 vs V2

Timeframe: 6 weeks

Trial details

NCT IDNCT03114696

SponsorInQpharm Group

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09-29

View on ClinicalTrials.gov More Insomnia, Nonorganic trials