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Cross-sectional survey on insomnia and caregiver burden in Alzheimer's disease

Cross-sectional survey on insomnia and caregiver burden in Alzheimer's disease - Cross-sectional survey on insomnia and caregiver burden in Alzheimer's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000032301
Enrollment
500
Registered
2018-04-18
Start date
2018-04-19
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

Insomnia with Alzheimer&#39

Interventions

None listed

Sponsors

MSD K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age 20 years old or older 2) Informal caregivers of mild to moderate AD patients with experience of insomnia symptom in Japan, who are living with the patients. 3) A primary caregiver, if care responsibilities are shared with another person.

Exclusion criteria

Exclusion criteria: 1) A caregiver of two or more persons. 2) A caregiver with schizophrenia, depression or bipolar disorder diagnosed by a doctor 3) A caregiver of the following patient - Patients with mental disorder, or mental retardation - Patients with dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Parkinson's disease, sleep apnea using CPAP or BIPAP. - Patients with physical disabilities by injury or congenital abnormality (upper or lower limb loss/impairment (including bone fracture), visual impairment, hearing loss etc.) which require someone's help

Design outcomes

Primary

MeasureTime frame
Correlation between caregiver burden as measured by BIC-11 and patients sleep as measured by SDI in AD.

Secondary

MeasureTime frame
- Correlation between caregiver sleep as measured by PSQI and patients sleep as measured by SDI in AD. - Correlation between caregiver QOL as measured by SF-12 and patients sleep as measured by SDI in AD. - Correlation between caregiver depression (PHQ-9:>=10) and patients sleep as measured by SDI in AD. - Correlation between caregiver time spent in patients care and patients sleep as measured by SDI in AD.

Countries

Japan

Contacts

Public ContactShoki Okuda

MSD K.K. Medical Affairs

ldgproject@merck.com03-6272-1067

Outcome results

None listed

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