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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 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Sleep Well Diffuser Blend followed by Sleep Well Roll-On
Kosttillskott: 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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Sleep Quality as Assessed by Sleep Quality Score (SQS)
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Participant-Perceived Change in Sleep Quality
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Saie Beauty

Samarbetspartners

Citruslabs

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 april 2026

Primärt slutförande (Faktisk)

1 juni 2026

Avslutad studie (Faktisk)

1 juni 2026

Studieregistreringsdatum

Först inskickad

11 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

19 augusti 2026

Första postat (Faktisk)

21 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 20830

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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