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Acetaminophen for sleep problems in the elderly.

The effects of acetaminophen versus placebo on self-reported sleep problems in a geriatric population: A multicenter, randomized, double-blind, placebo-controlled cross-over trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21250
Enrollment
150
Registered
2011-02-10
Start date
2011-06-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Sleep problems, in particular insomnia.

Interventions

Acetaminophen versus placebo. Acetaminophen will be given in a dosis of 1000 mg a day during two weeks. No medication will be taken in the first week.

Sponsors

Academic Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged ¡Ý 65 years; 2. Subjective sleep problems during > 1 month, at least once a week; 3. Patients must be willing and medically able to receive therapy according to the protocol for the duration of the study; 4. Patients must be able to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients using any acetaminophen on a regular basis (at least once a day) because of pain or who have an indication to start with it (VAS score > 6); 2. Patients who will be admitted to the hospital directly after the visit of the outpatient clinic; 3. MMSE 120 U/l, determined in the last six months; 7. Daily alcohol intake ¡Ý 4 units a day; 8. Suicidal tendencies to be assesed by the attending physician; 9. Participation in other trials concerning sleep.

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
In a subgroup of 15 patients we will measure the periods of wake and sleep with an actigraph during the three weeks of the study.

Contacts

Public ContactE.M.M. Glind, van de

Postbus 22660

e.m.vandeglind@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)