Short SleepersNCT07567560
The Short Sleep Study
An observational study of Short Sleepers, run by Danisco at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Short Sleepers
- How many people
- 34 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Oct 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Men between 20 - 50 years of age and pre-menopausal women between 20 - 45 years of age (inclusive).
- Consistent schedule during daytime hours.
- Body Mass Index (BMI) 18.5 - 35 kg/m2 (inclusive).
- Good physical and mental health as established by self-reported medical history and evaluated by a study investigator.
- Willingness to maintain and record their general habits, eating, and daily activity/exercise pattern for the study period.
- Willingness to maintain typical sleep hygiene patterns (e.g. sleep location, temperature, environment).
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- Willingness to maintain their current pattern of alcohol consumption for the duration of the study.
- Willing and able to participate fully in all aspects of the study and complete all study procedures, including providing signed informed consent.
- Willing and able to attend two in-person visits at a trial site
- 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
- Has regular bowel habits, on at least 5 days a week.
- 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
- 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.
- 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.
- Average KSS Score of 1-3 during the screening period.
Who cannot join
- 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.
- Extreme chronotypes, those who regularly go to sleep prior to 8:00pm.
- Any current diagnosed or self-reported gastrointestinal disorder, including Crohn's disease, ulcerative colitis, celiac disease, IBS, or functional bowel disorder or chronic heartburn.
- 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.
- Currently taking medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.
- 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.
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- Neurodegenerative diseases (including multiple sclerosis, Parkinson's disease, Alzheimer's disease, dementia).
- 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.
- Drug abuse or dependence, including consistent recreational substance use such as marijuana.
- 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.
- Recent history (current use or within the past 1 month) of smoking, vaping or other use of nicotine-containing products.
- Diagnosed neuropsychiatric disorders or symptoms possibly affecting sleep e.g. (generalized anxiety disorder (GAD), major depressive disorder (MDD), bipolar disorder, schizophrenia)
- 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).
- Any use of probiotic supplements in the past 2 weeks.
- Any use of proton pump inhibitors (PPIs) in the past 2 weeks.
- Any use of laxatives or antidiarrheals in the past 4 weeks.
- Any use of non-steroidal anti-inflammatory drugs (NSAIDs) for 5 or more consecutive days in the past 4 weeks.
- Pregnant or breastfeeding or planning to become pregnant.
- 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.
- Planned overnight travel during the study.
- Females experiencing perimenopausal or menopausal symptoms, or those who have been diagnosed as perimenopausal or menopausal by a physician.
- Any diagnosed condition or undiagnosed symptom which disrupts sleep, including, but not limited to, hyperthyroidism, night sweats, restless legs, or poorly controlled allergic rhinitis.
- Varying work schedule and/or shift workers who work overnight shifts (e.g. 3rd shift, working late night to early morning hours).
- Any other personal or medical condition that the investigator believes may bias or confound the results.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Lindus Health
Boston, Massachusetts, 02111
Patient Recruitment Coordinator, 833-711-1429, shortsleep@lindushealth.com
- Recruiting
AccuMed
Garden City, New York, 11530
Leanne Cossu, 516-746-2190, accumed@aol.com
- Recruiting
New Dawn Wellness and Medical Research Center
Houston, Texas, 77082
Moses Ukazu, 281-809-5467, mukazu@ndwmc.com
- Recruiting
Global Life Research Network
Miami, Florida, 33155
Emily Lozano, (786) 558-8892, emily@globalliferesearch.com
About this study
Official title: 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.
- Conditions
- Short Sleepers
- Keywords
- short sleep, short sleepers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome characterization of the short sleeper population
Identify a specific fecal microbiota composition related to short sleep
Measured: baseline through day 10 of the study period.
Comparison of natural short sleeper microbiomes to participants from the night owl study.
Compare microbiome (composition and function) of natural short sleeprs to those individuals enrolled into the night owl study.
Measured: From baseline through day 10 of the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start23 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short SleepersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567560
- Sponsor's protocol ID
- IFF-NO-002
- Status last verified
- Nov 2025
- First submitted
- 10 Nov 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short Sleep Study: A Non-interventional Study of Fecal Microbiota in Natural Short Sleepers
- ClinicalTrials.gov ID
- NCT07567560
- Acronym / sponsor ID
- IFF-NO-002
- Conditions
- Short Sleepers
- Keywords
- short sleep, short sleepers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 May 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (15 listed)
- Men between 20 - 50 years of age and pre-menopausal women between 20 - 45 years of age (inclusive).
- Consistent schedule during daytime hours.
- Body Mass Index (BMI) 18.5 - 35 kg/m2 (inclusive).
- Good physical and mental health as established by self-reported medical history and evaluated by a study investigator.
- Willingness to maintain and record their general habits, eating, and daily activity/exercise pattern for the study period.
Key exclusion criteria (24 listed)
- 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.
- Extreme chronotypes, those who regularly go to sleep prior to 8:00pm.
- Any current diagnosed or self-reported gastrointestinal disorder, including Crohn's disease, ulcerative colitis, celiac disease, IBS, or functional bowel disorder or chronic heartburn.
- 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.
- Currently taking medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiome characterization of the short sleeper population
Time frame: baseline through day 10 of the study period.
Identify a specific fecal microbiota composition related to short sleep
Comparison of natural short sleeper microbiomes to participants from the night owl study.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Short Sleepers
Not yet recruiting
Homeostatic Regulation of Sleep in Short Sleepers
Short Sleepers, Normal Sleepers
Recruiting
Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period
Sleep Deprivation
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Sleepers, run by Danisco at 4 sites in United States.
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 15 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome characterization of the short sleeper population (time frame: baseline through day 10 of the study period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.