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Acetaminophen for SLeep Problems in Elderly Patients

Acetaminophen for SLeep Problems in Elderly Patients - ASLEEP

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36455
Enrollment
150
Registered
2011-03-03
Start date
2011-07-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Insomnia

Interventions

Acetaminophen 1000 mg once daily versus placebo

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Aged * 65 years Subjective sleep problems during > 1 month, at least once a week Patients must be willing and medically able to receive therapy according to the protocol for the duration of the study Patients must be able to give informed consent

Exclusion criteria

Exclusion criteria: Patients using acetaminophen chronically because of pain or who have an indication to start with it (VAS score > 6). Patients, men and women, who have 120 U/l Suicidal tendencies according to the attending physician Alcohol abuse > 4 units/day

Design outcomes

Primary

MeasureTime frame
Primary endpoint will be the self-reported sleep problems at the end of follow-up, measured by means of the Insomnia Severity Index (ISI).

Secondary

MeasureTime frame
Sleep efficiency, sleep onset latency, wake after sleep onset, early morning awakening, time in bed, total sleep time, registered in a sleep diary Mark for their nights rest Adverse effects

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)