An interventional study of Qualia Sleep Formula A and Qualia Sleep Formula B in Sleep Quality, sponsored by Qualia Life Sciences. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Qualia Life Sciences · Not applicable, Interventional, and Other
Among 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States — 146 open to participants now, 183 under way, 5 of them phase 3. Sleep Initiation and Maintenance Disorders · United States.
Among the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States, this one is the 289th largest by planned enrollment of the 855 interventional ones that give a count, is one of 60 that started in 2026, is one of 577 with no phase, reaches primary completion later than 41 of the 182 other live ones, and was the 887th registered.
2,726 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 728 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →146 of the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States are open now. Recruiting first, the newest first:
Florida State University · Sites in United States
Ages 6–13 · Healthy volunteers
University of Pittsburgh · Sites in United States
Ages 65+ · Women only
Eight Sleep Inc. · Sites in United States
Ages 45+ · Healthy volunteers
Proactive Life Inc · Sites in United States
Ages 55+
Spectrum Clinical Research, LLC · Sites in United States
Ages 45–65 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 388 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 206 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
903 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 40 · Phase 2 103 · Phase 3 77 · Phase 4 78
First in 1997; this study’s year is marked. 60 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 68 across 2,353 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Median enrollment 60 across the 855 interventional studies, 72 across the 48 observational. Of the 660 that completed or were terminated, 243 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
186 of 903 have an industry lead sponsor. The 10 most frequent:
Qualia Life Sciences is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
Qualia Life Sciences has 1 study filed under Sleep Initiation and Maintenance Disorders — fewer than ten, so there is no comparison to draw.
79 of the studies in Sleep Initiation and Maintenance Disorders with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568367Phase 3Axsome Therapeutics, Inc.Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) | 2026-12 |
| NCT06655883Phase 3Merck Sharp & Dohme LLCA Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098) | 2027-06-24 |
| NCT07336277Phase 3Emory UniversitySleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients | 2027-07 |
| NCT06953869Phase 3Vanda PharmaceuticalsEvaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia | 2027-11 |
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
Add all 79 to your calendar (.ics) → With an account.
Among the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a randomized, open-label, 4-arm pilot study designed to evaluate the efficacy and tolerability of four Qualia Sleep formulations (Formulas A, B, C, and D) in healthy adults aged 18 years and older who report poor sleep quality. The investigational products are encapsulated dietary supplements intended to support sleep quality and satisfaction. Approximately 100 participants will be allocated to one of four arms (n≈25 per arm) and will take 2 capsules of their assigned Qualia Sleep formula once daily for 28 consecutive days, administered 30-60 minutes before bedtime. The primary objective is to assess changes in sleep quality and satisfaction from baseline to Day 28 using the PROMIS Sleep Disturbance - Short Form 8b, with secondary outcomes including sleep-related impairment, pre-sleep arousal, and overall safety and tolerability. All study data, including self-reported sleep and safety questionnaires, will be collected electronically via secure links; there are no in-person visits or clinic-based assessments.
The primary aim of this open-label, four-arm pilot study is to evaluate the efficacy of four Qualia Sleep formulations (A, B, C, and D) in improving sleep quality and satisfaction over 28 days in adults reporting sleep disturbances, as assessed by the PROMIS Sleep Disturbance - Short Form 8b (PROMIS-SD). The primary objective is to determine the change from baseline to day 28 in PROMIS-SD scores across all participants using each formulation. Secondary objectives are to: (1) assess changes in PROMIS-SD in a subgroup with more pronounced baseline sleep disturbance; (2) evaluate changes in sleep-related daytime impairment using the PROMIS Sleep-Related Impairment Short Form 8a (PROMIS-SRI) in both the overall sample and the higher-disturbance subgroup; (3) examine changes in somatic and cognitive pre-sleep arousal as measured by the Pre-Sleep Arousal Scale (PSAS) in both the overall sample and the higher-disturbance subgroup; and (4) characterize the safety and tolerability profile of each formulation over the 28-day supplementation period. Participants take 2 capsules once daily at night, 30-60 minutes before bed, for 28 consecutive days. Participants complete regular check-in surveys on days 1, 3, 7, 14, 21, and 28. All study data will be collected electronically using secure survey links completed remotely on participants' own devices.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants take Qualia Sleep Formula A capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
Dietary Supplement: Qualia Sleep Formula A
Participants take Qualia Sleep Formula B capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
Dietary Supplement: Qualia Sleep Formula B
Participants take Qualia Sleep Formula C capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
Dietary Supplement: Qualia Sleep Formula C
Participants take Qualia Sleep Formula D capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
Dietary Supplement: Qualia Sleep Formula D
Oral Capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Change from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score
Change from baseline to day 28 in PROMIS-SD scores across all participants using each formulation. The 8-item questionnaire assesses self-reported perceptions of sleep quality, sleep depth and restoration, and difficulties and dissatisfaction with sleep during the past 7 days. Total raw score ranges from 8 to 40, with higher scores indicating greater sleep disturbance.
Time frame: Baseline to Day 28
Change from baseline in PROMIS Sleep Disturbance (PROMIS-SD) score in the higher-disturbance subgroup
Change in PROMIS-SD in a subgroup with more pronounced baseline sleep disturbance.
Time frame: Baseline to Day 28
Change from baseline in PROMIS Sleep-Related Impairment v1.0 Short Form 8a (PROMIS-SRI) score
Changes in sleep-related daytime impairment using the PROMIS-SRI in both the overall sample and the higher-disturbance subgroup. The 8-item questionnaire assesses daytime consequences of poor sleep. Total raw score ranges from 8 to 40, with higher scores indicating greater sleep-related impairment.
Time frame: Baseline to Day 28
Change from baseline in Pre-Sleep Arousal Scale (PSAS) somatic and cognitive arousal scores
Changes in somatic and cognitive pre-sleep arousal as measured by the PSAS in both the overall sample and the higher-disturbance subgroup. Two subscales (somatic items 1-8, cognitive items 9-16), each scoring 8-40, with higher scores indicating greater pre-sleep arousal.
Time frame: Baseline to Day 28
Safety and tolerability profile
Characterize the safety and tolerability profile of each formulation over the 28-day supplementation period using the Safety and Tolerability Questionnaire assessing symptoms including increased anxiety/worry, headache, mood changes, stomach upset/nausea, dizziness, bloating, itching, and sexual dysfunction. Higher score = worsening of symptoms.
Time frame: Days 1, 3, 7, 14, 21, and 28
Follow-Up Questionnaire (overall product experience and rating)
Overall experience of the product, product rating, and purchase interest. Success criteria for the test product is at least 80% excellent + good ratings on the overall experience question, with more than 25% of all ratings being excellent.
Time frame: 5-7 days after final dose
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Oct 2026, 1 month after the start.
Of 78 industry-sponsored interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 23. This study's planned 1 month is below that.
Counting every sponsor, half of 1,289 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Oct 5, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders →