insomnia stoornis Insomnia sleeplessness
Conditions
Interventions
Participants are treated during 12 weeks with either amitriptyline (starting
with 10 mg per day, respectively, and, if ineffective, possible doubling of
this dose after 3 weeks, and stopping after 1
Sponsors
Ziekenhuisvoorzieningen Gelderse Vallei
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adults aged 18 - 85 years and older visiting the outpatient clinic department of neurology. - Presence of insomnia disorder conform DSM-5, i.e. sleep problems in at least 3 nights a week, for at least 3 months with consequences for daytime functioning, the sleep problem cannot be better explained by or occurs exclusively during the course of another sleep disorder (e.g. sleep related breathing disorder, parasomnia) - Score of >=10 on the Insomnia Severity Index (ISI) - Have a medical condition and / or chronic pain (> 3 months).
Exclusion criteria
Exclusion criteria: - Habitual night shift worker - Untreated sleep related breathing disorder - Wish to continue over-the-counter sleep aids as melatonin and medicinal cannabis - Use of off-label amitriptyline for insomnia in the past year - Being unable to follow study instructions and fill out the study questionnaires (in Dutch) - A known diagnosis of dementia - History of delirium - Pregnancy, lactation or wish to become pregnant in the coming 6 months - Terminal illness (prognosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the mean subjective insomnia severity score, measured by the insomnia severity index (ISI). Primary endpoint is at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| During the follow-up period maintenance of the treatment response assessed operationalized as having a >= 8 point reduction on the ISI Secondary outcomes include sleep quality quantified by sleep efficiency, questionnaires on daytime functioning and symptoms (fatigue, emotional complaints, physical functioning impairment of functioning). Possible moderators are type of insomnia, dysfunctional attitudes and beliefs about sleep, pre sleep arousal. Furthermore adverse events and treatment evaluation (side effects, withdrawal symptoms, and adherence) are assessed. | — |
Countries
Netherlands
Outcome results
None listed