BridgeMD
TIMELAPSE study
EU CTIS ID: 2024-518320-71-00
What this study is testing
The main objective of the study is to determine whether low dose amitriptyline (10-20 mg) in chronic insomnia coexisting with medical conditions is as effective as CBT-I in improving subjective sleep.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults aged 18 - 85 years 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 or more on the lnsomnia Severity lndex (lSl)
- Have a medical condition and/or chronic pain (> 3 months).
You likely can't join if
- Habitual night shift worker
- Suicide risk
- Epilepsy
- Ocular Hypertension / Glaucoma
- Presence of a severe psychiatric disorder not in remission or adequately treated
- Current alcohol or drug abuse or addiction (benzodiazepine excluded)
See the full eligibility criteria
- Adults aged 18 - 85 years 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 or more on the lnsomnia Severity lndex (lSl)
- Have a medical condition and/or chronic pain (> 3 months).
- Habitual night shift worker
- Suicide risk
- Epilepsy
- Ocular Hypertension / Glaucoma
- Presence of a severe psychiatric disorder not in remission or adequately treated
- Current alcohol or drug abuse or addiction (benzodiazepine excluded)
- Participation in other interventional medical scientific studies
- Current use of psychopharmaceuticals other than benzodiazepines
- Current use of antimycotica
- Allergy for amitriptyline
- Cardiac arrhythmia / blockade / Long QT syndrome / Brugada syndrome
- Untreated sleep related breathing disorder
- Family history of acute cardiac death
- Recent myocardial infarction (within the past 90 days)
- Angina pectoris / coronary insufficiency
- Severe renal insufficiency (GFR <10) and/or severe liver dysfunction
- 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 < 1 year)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.