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Verification of sleep effect by neck back warming before bedtime

Verification of sleep effect by neck back warming before bedtime - Verification of sleep effect by neck back warming

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056811
Enrollment
70
Registered
2025-02-01
Start date
2025-01-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

1. Observation period for 1 week. 2. Applying warming sheet to neck back before bedtime for 4 weeks. 3. Follow up period for 2 weeks. 1. Observation period for 1 week. 2. Applying non-warming she

Sponsors

Kao Corporation
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female aged 20-49 2. Female who has mild sleep difficulties 3. Person who agrees to use the wearable device (Fitbit)

Exclusion criteria

Exclusion criteria: 1. Individuals with a history or current sleep disorders or psychiatric conditions. 2. Patients diagnosed with hypersomnia, sleep apnea, or sleep paralysis. 3. Those experiencing pain, itching, fever, diarrhea, or frequent urination that significantly disrupts sleep. 4. Individuals suffering from hay fever or allergic rhinitis that may disturb sleep. 5. Those with a history, current, or suspected cardiovascular diseases, neurological disorders, or alcohol dependence. 6. Individuals who smoke. 7. Those who regularly use medications, health supplements, or functional foods related to sleep, stress, or fatigue. 8. Individuals consuming more than the recommended alcohol amount (around 20g of pure alcohol daily) on more than three days a week, or who drink alcohol in bed. 9. Those who sleep less than 5 hours, or whose sleep wake times vary by more than 2 hours between weekdays and weekends. 10. Individuals working shifts or whose sleep schedules may change due to overseas business trips during the study period. 11. Those who develop eczema or hives when exposed to heat, or who are temperature-sensitive. 12. Individuals who have had allergic reactions (rashes, redness, itching) to medications or cosmetics. 13. Those with sensitive skin who may experience irritation from adhesive bandages or tapes. 14. Individuals with neck swelling or inflammation, cuts, grazes, eczema, or rashes. 15. Those who have experienced negative sensations or skin issues from heating pads or similar products in the past. 16. Pregnant individuals or those planning to become pregnant during the study. 17. Those uncomfortable sleeping with an activity monitor (Fitbit) that tracks sleep patterns. 18. Individuals currently participating in other studies or planning to during this study's participation. 19. Those deemed unsuitable for participation by the principal investigator for other reasons, including noncompliance with study protocols.

Design outcomes

Primary

MeasureTime frame
Subjective Sleep Scores

Secondary

MeasureTime frame
- Pre-Sleep Arousal Scale -Ford Insomnia Response to Stress Test -Profiles of mood scale -Sleep indicators by Fitbit

Countries

Japan

Contacts

Public ContactTomohisa Ichiba

Kao Corporation Human HealthCare Research Lab

ichiba.tomohisa@kao.com+81-3-5630-7271

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026