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A Clinical Trial to Evaluate the Effects of a Topical Roll-on and Diffuser Blend on Sleep Quality and Sleep Duration

19. august 2026 opdateret af: Saie Beauty

This study will evaluate the effects of the Saje Sleep Well topical roll-on and the Saje Sleep Well diffuser blend on sleep quality and sleep duration in adults who have experienced issues with sleep quality and sleep duration over the past four weeks. The trial involves 40 participants and is conducted over seven weeks in total, including a one-week Fitbit calibration period and a six-week study intervention.

During Weeks 1-3, participants will use the Sleep Well Diffuser Blend nightly. During Weeks 4-6, participants will switch to the Sleep Well Roll-On, applied to the wrists, throat, and temples one hour before bedtime. Sleep measurements will be collected via Fitbit device and self-reported questionnaires, including the validated Sleep Quality Score (SQS), at Baseline and at the end of Weeks 2, 3, 5, and 6.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89101
        • Citruslabs

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Adults aged 18-60
  • Anyone who has experienced issues regarding sleep quality over the past four weeks
  • Anyone who has experienced issues regarding sleep duration over the past four weeks
  • Anyone who is generally healthy - does not live with any uncontrolled chronic disease
  • If taking oral over-the-counter supplements or herbal remedies targeted at sleep quality and sleep duration, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration
  • Willing to refrain from introducing any products or any new forms of prescription medication or supplements that target sleep quality and sleep duration for the study duration
  • Resides in the United States
  • Anyone willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial

Exclusion Criteria:

  • Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
  • Anyone diagnosed with a sleep disorder or taking prescription medications for sleep
  • Anyone who is involved with shift work
  • Anyone with any allergies or sensitivities to any of the study product ingredients
  • Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period)
  • Anyone unwilling to follow the study protocol
  • Anyone who identifies as having sensitive skin
  • Anyone with a history of skin cancer or any pre-cancerous lesions on their skin
  • Anyone with a history of substance abuse or heavy alcohol use (more than 14 drinks per week)
  • Anyone who is currently a smoker or has been a smoker in the past 3 months
  • Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration
  • Anyone with chronic skin conditions (e.g., dermatitis, eczema, psoriasis)
  • Anyone who has epilepsy
  • Anyone with asthma, COPD, or significant respiratory conditions
  • Anyone who suffers from migraines or headaches that are triggered or worsened by smells, perfumes, essential oils, or fragranced products
  • Anyone with hypertension or taking antihypertensive medications

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sleep Well Diffuser Blend followed by Sleep Well Roll-On
Kosttilskud: Sleep Well Diffuser Blend followed by Sleep Well Roll-On
All participants use the Sleep Well Diffuser Blend during Weeks 1-3 (20 drops added to diffuser on intermittent mode, one hour before bedtime, run throughout the night), then switch to the Sleep Well Roll-On during Weeks 4-6 (applied to wrists, throat, and temples once daily, one hour before bedtime)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Sleep Quality as Assessed by Sleep Quality Score (SQS)
Tidsramme: Baseline, Week 2, Week 3, Week 5, Week 6
Change from baseline in Sleep Quality Score (SQS), as assessed by the validated SQS questionnaire.
Baseline, Week 2, Week 3, Week 5, Week 6
Change in Sleep Duration as Assessed by Fitbit Sleep Duration
Tidsramme: Baseline, Week 2, Week 3, Week 5, Week 6
Change from baseline in sleep duration measured by the participant's Fitbit device. Sleep duration will be summarized at each assessment time point.
Baseline, Week 2, Week 3, Week 5, Week 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant-Perceived Change in Sleep Quality
Tidsramme: Baseline, Week 2, Week 3, Week 5, Week 6
Change from baseline in participant-reported sleep quality, as assessed by the study self-reported questionnaire.
Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Sleep Duration
Tidsramme: Baseline, Week 2, Week 3, Week 5, Week 6
Change from baseline in participant-reported sleep duration, as assessed by the study self-reported questionnaire.
Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Fatigue
Tidsramme: Baseline, Week 2, Week 3, Week 5, Week 6
Change from baseline in participant-reported fatigue, as assessed by the study self-reported questionnaire.
Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Energy Levels
Tidsramme: Baseline, Week 2, Week 3, Week 5, Week 6
Change from baseline in participant-reported energy levels, as assessed by the study self-reported questionnaire.
Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Overall Health
Tidsramme: Baseline, Week 2, Week 3, Week 5, Week 6
Change from baseline in participant-reported overall health and well-being, as assessed by the study self-reported questionnaire.
Baseline, Week 2, Week 3, Week 5, Week 6

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Saie Beauty

Samarbejdspartnere

Citruslabs

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2026

Primær færdiggørelse (Faktiske)

1. juni 2026

Studieafslutning (Faktiske)

1. juni 2026

Datoer for studieregistrering

Først indsendt

11. august 2026

Først indsendt, der opfyldte QC-kriterier

19. august 2026

Først opslået (Faktiske)

21. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20830

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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