Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

The Short Sleep Study

6. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

34

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Florida
      • Miami, Florida, Vereinigte Staaten, 33155
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02111
    • New York
      • Garden City, New York, Vereinigte Staaten, 11530
        • Rekrutierung
        • AccuMed
        • Kontakt:
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77082
        • Rekrutierung
        • New Dawn Wellness and Medical Research Center
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Microbiome characterization of the short sleeper population
Zeitfenster: 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.
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. Oktober 2025

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. April 2027

Studienanmeldedaten

Zuerst eingereicht

10. November 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. April 2026

Zuerst gepostet (Tatsächlich)

5. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. August 2026

Zuletzt verifiziert

1. November 2025

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • IFF-NO-002

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren