Objective: To investigate whether acetaminophen is effective in treating self-reported sleep problems.
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
The prevalence of sleep disorders increases with age. Sleep disorders have
serious health implications and may be relaterd to serious underlying diseases.
Many older people use hypnotics like benzodiazepines, although these
medications have side effects and often lead to habituation.
If, however, there would be an easy treatment for sleep problems, many patients
could benefit. Some people use acetaminophen as a sleeping-pill and are
convinced this works. Few is known about the effect of acetaminophen at sleep.
Acetaminophen might be a simple and cheap treatment for sleep disorders with
low side effects. The ASLEEP study could contribute to our knowledge about
treatment of sleep problems.
Study objective
Objective: To investigate whether acetaminophen is effective in treating
self-reported sleep problems.
Study design
A randomized, multicenter placebo controlled double-blind trial.
Intervention
Acetaminophen 1000 mg once daily versus placebo
Study burden and risks
In total, the study takes three weeks plus the visit to the outpatient clinic
after 4 to 6 weeks. Patients need not to stay in the hospital. Neither do they
have to change their regular medication. During the study, they should fill in
the sleep diary every day and the ISI weekly. At the end of follow-up, they
will return to the outpatient clinic of their hospital or there will be contact
by phone. This final control will be done, when possible, at the same time of
their regular check-up.
The risks associated with this study consist of the possible adverse effects of
acetaminophen. This is widely used an analgesic and has proved to be effective
and safe. Even though, close monitoring of study participants will take place
for assessment of defined side effects.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
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
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 <6 points on the Pittsburgh Sleep Quality Index
MMSE of <18
Patients who will be admitted to the hospital directly after the visit of the outpatient clinic.
Patients who sleep badly because of (treatable) social, psychic or somatic reasons:
Acute heart failure needing diuretic treatment
OSAS
A depression needing the start of antidepressants
A delirium or anxiety disorder
Recent life event, e.g. loss of a loved one
Planned removal to a nursing home
Life expectancy less than three months according to the attending physician
Liver insufficiency: alanine aminotransferase > 120 U/l
Suicidal tendencies according to the attending physician
Alcohol abuse > 4 units/day
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-023517-57-NL |
| CCMO | NL33732.018.10 |