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The Short Sleep Study

6 agosto 2026 aggiornato da: Danisco

The Short Sleep Study: A Non-interventional Study of Fecal Microbiota in Natural Short Sleepers

Natural Short Sleepers are defined as individuals who sleep fewer than 6 hours per night without any impact on health or daytime mental fatigue levels. Emerging evidence suggests that, in the general population, the gut microbiota would be negatively influenced by this sleep duration. It is possible that Natural Short Sleepers have a distinct gut microbiome. Identifying differences in microbiota composition may lead to an opportunity to improve health outcomes in those with inadequate or poor sleep.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

34

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Florida
      • Miami, Florida, Stati Uniti, 33155
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02111
        • Reclutamento
        • Lindus Health
        • Contatto:
    • New York
      • Garden City, New York, Stati Uniti, 11530
        • Reclutamento
        • AccuMed
        • Contatto:
    • Texas
      • Houston, Texas, Stati Uniti, 77082
        • Reclutamento
        • New Dawn Wellness and Medical Research Center
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Natural Short Sleepers are defined as individuals who sleep between 4 and 5.5 hours per night without any impact on health or daytime mental fatigue levels.

Descrizione

Inclusion:

  1. Men between 20 - 50 years of age and pre-menopausal women between 20 - 45 years of age (inclusive).
  2. Consistent schedule during daytime hours.
  3. Body Mass Index (BMI) 18.5 - 35 kg/m2 (inclusive).
  4. Good physical and mental health as established by self-reported medical history and evaluated by a study investigator.
  5. Willingness to maintain and record their general habits, eating, and daily activity/exercise pattern for the study period.
  6. Willingness to maintain typical sleep hygiene patterns (e.g. sleep location, temperature, environment).
  7. Willingness to maintain their current pattern of alcohol consumption for the duration of the study.
  8. Willing and able to participate fully in all aspects of the study and complete all study procedures, including providing signed informed consent.
  9. Willing and able to attend two in-person visits at a trial site
  10. Completes all required procedures (screening questionnaire and ePROs) during the 14-day screening period 10a. Two instances of the sleep diary and Karolinska Sleepiness Scale may be missed by the participant without impacting eligibility
  11. Has regular bowel habits, on at least 5 days a week.
  12. Pittsburgh Sleep Quality Index (PSQI) global score of ≤7 and a sleep efficiency score of ≥80%, self-reported during the screening period. Additionally, no more than one score of 3 is permitted across Question 5 sub-items, and no score of 3 is permitted in Question 10 sub-items, if a bed partner is present
  13. Sleep, on average, 4-5.5 hours per night, verified via participant self-report during the screening period. If the participant's average is within the 4-5.5 hour range but slept more than 5.5 hours on any of the nights their eligibility will be assessed per PI/Sponsor discretion. Note: Oura ring data from the run-in period will be reviewed to confirm eligibility based on PI/Sponsor discretion.
  14. Report feeling refreshed with no desire to nap during the daytime, with a score of ≤4 on the Epworth Sleepiness Scale (ESS) evaluated during the screening period.
  15. Average KSS Score of 1-3 during the screening period.

Exclusion:

  1. Ever diagnosed with or self-reports a sleep disorder, including sleep apnea, habitual snoring (defined as loud, persistent snoring 3 or more nights per week), insomnia, narcolepsy, or parasomnias.
  2. Extreme chronotypes, those who regularly go to sleep prior to 8:00pm.
  3. Any current diagnosed or self-reported gastrointestinal disorder, including Crohn's disease, ulcerative colitis, celiac disease, IBS, or functional bowel disorder or chronic heartburn.
  4. Regularly wakes up during the night 5 or more times per night for a cumulative amount of 30 minutes as observed via self-report during the screening period, per PI discretion.
  5. Currently taking medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.
  6. Have taken in the last 3 months medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.
  7. Neurodegenerative diseases (including multiple sclerosis, Parkinson's disease, Alzheimer's disease, dementia).
  8. Recent history (past year) of alcohol abuse or dependence. Defined as regularly drinking more than 12 drinks for females and more than 20 drinks for males per week and based on PI discretion.
  9. Drug abuse or dependence, including consistent recreational substance use such as marijuana.
  10. Binge drinking behavior, defined as 4 or more alcoholic drinks for women or 5 or more alcoholic drinks for men in one sitting on 2 or more occasions, within the past 1 month with final decision per PI discretion.
  11. Recent history (current use or within the past 1 month) of smoking, vaping or other use of nicotine-containing products.
  12. Diagnosed neuropsychiatric disorders or symptoms possibly affecting sleep e.g. (generalized anxiety disorder (GAD), major depressive disorder (MDD), bipolar disorder, schizophrenia)
  13. Any use of systemic antibiotics in the past 3 months. This does not include topical or targeted antibiotic use (ointment, spray, eye drop, ear drop).
  14. Any use of probiotic supplements in the past 2 weeks.
  15. Any use of proton pump inhibitors (PPIs) in the past 2 weeks.
  16. Any use of laxatives or antidiarrheals in the past 4 weeks.
  17. Any use of non-steroidal anti-inflammatory drugs (NSAIDs) for 5 or more consecutive days in the past 4 weeks.
  18. Pregnant or breastfeeding or planning to become pregnant.
  19. Personal circumstances affecting stress or sleep (e.g. serving as a caretaker/required to wake up during sleep/major change in personal life). Note: Life situations causing stress or challenges in sleep that are considered shortterm, per PI discretion, may be considered for re-screening 4 weeks after the life situation has resolved, meaning it is no longer causing stress or challenges in sleep.
  20. Planned overnight travel during the study.
  21. Females experiencing perimenopausal or menopausal symptoms, or those who have been diagnosed as perimenopausal or menopausal by a physician.
  22. Any diagnosed condition or undiagnosed symptom which disrupts sleep, including, but not limited to, hyperthyroidism, night sweats, restless legs, or poorly controlled allergic rhinitis.
  23. Varying work schedule and/or shift workers who work overnight shifts (e.g. 3rd shift, working late night to early morning hours).
  24. Any other personal or medical condition that the investigator believes may bias or confound the results.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Natural Short Sleepers
Natural short sleepers (NSS) sleep on average <6 hours per night, but feel no need to sleep longer, and do not show signs of daytime sleepiness or fall asleep in low stimulus environments.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Microbiome characterization of the short sleeper population
Lasso di tempo: baseline through day 10 of the study period.
Identify a specific fecal microbiota composition related to short sleep
baseline through day 10 of the study period.
Comparison of natural short sleeper microbiomes to participants from the night owl study.
Lasso di tempo: From baseline through day 10 of the study period.
Compare microbiome (composition and function) of natural short sleeprs to those individuals enrolled into the night owl study.
From baseline through day 10 of the study period.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 ottobre 2025

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 aprile 2027

Date di iscrizione allo studio

Primo inviato

10 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2026

Ultimo verificato

1 novembre 2025

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • IFF-NO-002

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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