title: Acetaminophen for self-reported sleep problems in an elderly population (ASLEEP): study protocol of a randomized placebo-controlled double-blind trial.
abstract: BACKGROUND
  The prevalence of sleep disorders increases with age. Sleep disorders may have serious health implications and may be related to serious underlying diseases. Many older people use hypnotics, like benzodiazepines, although these medications have serious side effects and often lead to habituation. Acetaminophen is one of the most frequently used off-label drugs for sleep disorders, although little is known about its effects. Our objective is to investigate whether acetaminophen is effective in treating self-reported sleep disorders in older people.
  
  
  METHODS
  Participants, aged 65 years or older (n=150), who have sleep disorders will be randomized for treatment with either acetaminophen 1000 mg or placebo, once daily at bedtime in a double-blind design. Eligible patients should be able to give informed consent, should not be cognitively impaired (Minimal Mental State Examination (MMSE) score≥20), should not have pain, and should not use acetaminophen on a regular basis because of pain complaints. The study will take three weeks to complete. During these three weeks, the participants register their sleep behavior in a sleep diary. The participants will use the study medication during the second and third week. The primary endpoint will be the self-reported sleep disorders at the end of week three, as measured by means of the Insomnia Severity Index (ISI). To validate these subjective sleep parameters against objectively measured indices of the sleep-wake pattern, we will measure the periods of wakefulness and sleep in a subgroup of participants, using an actigraph worn on the wrist during the entire study period.
  
  
  CONCLUSIONS
  The proposed study will contribute to our knowledge about the treatment of sleep disorders in an older population. There is a need for treatments for sleep disorders without serious adverse effects. Acetaminophen might be a simple and inexpensive alternative for the regimes that are currently used with older people.
  
  
  BACKGROUND
  The Netherlands National Trial Register NTR2747.
authors.affiliation: Department of Internal Medicine, Geriatrics Section, Academic Medical Center, P,O, Box 22660, Amsterdam, 1100 DD, The Netherlands. e.m.vandeglind@amc.nl.
authors.forename: Esther M M
authors.initials: EM
authors.lastname: van de Glind
authors.forename: Lotty
authors.initials: L
authors.lastname: Hooft
authors.forename: Linda R
authors.initials: LR
authors.lastname: Tulner
authors.forename: Joke H M
authors.initials: JH
authors.lastname: Tulen
authors.forename: Ingeborg M J A
authors.initials: IM
authors.lastname: Kuper
authors.forename: Hans L
authors.initials: HL
authors.lastname: Hamburger
authors.forename: Sophia E
authors.initials: SE
authors.lastname: de Rooij
authors.forename: Barbara C
authors.initials: BC
authors.lastname: van Munster
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use*; D000367:Age Factors; D000368:Aged; D002985:Clinical Protocols; D004311:Double-Blind Method; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D009426:Netherlands; D012107:Research Design; D012890:Sleep / Q000187:drug effects*; D012893:Sleep Wake Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D006993:Hypnotics and Sedatives; D000082:Acetaminophen