The Short Sleep Study
2026年8月6日 更新者: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.
調査の概要
状態
募集
研究の種類
観察的
入学 (推定)
34
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Florida
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Miami、Florida、アメリカ、33155
- 募集
- Global Life Research Network
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コンタクト:
- Emily Lozano
- 電話番号:(786) 558-8892
- メール:emily@globalliferesearch.com
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Massachusetts
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Boston、Massachusetts、アメリカ、02111
- 募集
- Lindus Health
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コンタクト:
- Patient Recruitment Coordinator
- 電話番号:833-711-1429
- メール:shortsleep@lindushealth.com
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New York
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Garden City、New York、アメリカ、11530
- 募集
- AccuMed
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コンタクト:
- Leanne Cossu
- 電話番号:516-746-2190
- メール:accumed@aol.com
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Texas
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Houston、Texas、アメリカ、77082
- 募集
- New Dawn Wellness and Medical Research Center
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コンタクト:
- Moses Ukazu
- 電話番号:281-809-5467
- メール:mukazu@ndwmc.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
Inclusion:
- 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).
- 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.
Exclusion:
- 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.
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Microbiome characterization of the short sleeper population
時間枠:baseline through day 10 of the study period.
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Identify a specific fecal microbiota composition related to short sleep
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baseline through day 10 of the study period.
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Comparison of natural short sleeper microbiomes to participants from the night owl study.
時間枠:From baseline through day 10 of the study period.
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Compare microbiome (composition and function) of natural short sleeprs to those individuals enrolled into the night owl study.
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From baseline through day 10 of the study period.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年10月23日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2027年4月1日
試験登録日
最初に提出
2025年11月10日
QC基準を満たした最初の提出物
2026年4月30日
最初の投稿 (実際)
2026年5月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月7日
QC基準を満たした最後の更新が送信されました
2026年8月6日
最終確認日
2025年11月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- IFF-NO-002
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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