|- candidate number||9094|
|- NTR Number||NTR2747|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-feb-2011|
|- Secondary IDs||10/267 METC AMC|
|- Public Title||Acetaminophen for sleep problems in the elderly.|
|- Scientific Title||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. |
|- hypothesis||Acetaminophen is effective in treating self-reported sleep problems, in particular insomnia.|
|- Healt Condition(s) or Problem(s) studied||Insomnia, Sleepproblems|
|- 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||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 <18 (26);
4. ¡Ü 5 points on the Pittsburgh Sleep Quality Index (27);
5. Patients who sleep badly because of (treatable) social, psychic or somatic reasons:
A. Acute heart failure needing diuretic treatment;
C. A depression needing the start of antidepressants;
D. A delirium or anxiety disorder;
E. Recent life event, e.g. loss of a loved one;
F. Planned removal to a nursing home in the coming three weeks;
G. Life expectancy less than three months according to the attending physician;
H. Other reasons, to be assessed and motivated by the attending physician.
6. Liver insufficiency: Alanine aminotransferase > 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2011|
|- planned closingdate||1-jun-2012|
|- Target number of participants||150|
|- 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.
|- 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||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. |
|- Timepoints||Inclusion during one year.|
Measurements at baseline and after 1 and 3 weeks. Patients will fill in a sleepdiary during 3 weeks.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| E.M.M. Glind, van de|
|- CONTACT for SCIENTIFIC QUERIES|| E.M.M. Glind, van de|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||The prevalence of sleep disorders increases with age. Sleep disorders have serious health implications and may be related 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.|
Therefore, we want to conduct a double-blind, randomized, placebo-controlled trial to investigate if acetaminophen is effective in treating self-reported sleep problems in a geriatric population.
|- Main changes (audit trail)|
|- RECORD||10-feb-2011 - 25-apr-2013|