A Clinical Trial to Evaluate the Effects of a Topical Roll-on and Diffuser Blend on Sleep Quality and Sleep Duration
19 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Nevada
-
Las Vegas, Nevada, États-Unis, 89101
- Citruslabs
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Sleep Quality as Assessed by Sleep Quality Score (SQS)
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Participant-Perceived Change in Sleep Quality
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 avril 2026
Achèvement primaire (Réel)
1 juin 2026
Achèvement de l'étude (Réel)
1 juin 2026
Dates d'inscription aux études
Première soumission
11 août 2026
Première soumission répondant aux critères de contrôle qualité
19 août 2026
Première publication (Réel)
21 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20830
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .