Comparison of melatonin, temazepam and placebo for the treatment of sleep problems in hospitalized older patients.

MelAtonin, Temazepam and plaCebo in Hospitalized older patients with sleeping problems.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21870

Enrollment

663

Registered

2017-12-18

Start date

2018-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleeping disorder, acute insomnia. Slaapstoornis, acute insomnia

Interventions

Patients are randomized to receive 1 out of 3 possible treatments: Treatment 1: Melatonin Dose: 1mg daily, ante nocte (with a maximum of 10 days) Administration: Orally Treatment 2: Temazepam

Eligibility

Inclusion criteria

Inclusion criteria: 1. 60 years or older 2. Admitted to the hospital for a medical or surgical reason 3. Experiencing new onset or aggravated sleep problems, for which an intervention is needed 4. Able to fill out a sleep questionnaire

Exclusion criteria

Exclusion criteria: 1. Inability to speak, understand or write Dutch 2. Lack of decision making capacity 3. Previously diagnosed dementia 4. Transferred from another hospital to one of the study centers, with insufficient information on previous use of sleep medication. 5. Expected stay in hospital of 13 units/week for women and >20 units/week for men 8. Drug interactions with melatonin or contra indications for benzodiazepine use

Design outcomes

Primary

Measure	Time frame
Sleep quality, measured with the quality of sleep (QOS) parameter of the Leeds Sleep Evaluation Questionnaire (LSEQ).	—

Secondary

Measure	Time frame
1) The other subscales of the LSEQ: getting to sleep (GTS), awakening from sleep (AFS) and behavior following wakening (BFW). 2) Good nights of sleep measured with a Numeric Rating Scale (NRS) . 3) Objective sleep parameters measured with actigraphy: sleep onset latency in minutes, sleep efficiency, number and duration of wake bouts and time awake after sleep onset in minutes. 4) Side effects related to study medication: Incidence of delirium during hospitalization, cognition, number of falls during hospitalization, complications and length of hospital stay in days.	—

Measure

Time frame

1) The other subscales of the LSEQ: getting to sleep (GTS), awakening from sleep (AFS) and behavior following wakening (BFW). 2) Good nights of sleep measured with a Numeric Rating Scale (NRS) . 3) Objective sleep parameters measured with actigraphy: sleep onset latency in minutes, sleep efficiency, number and duration of wake bouts and time awake after sleep onset in minutes. 4) Side effects related to study medication: Incidence of delirium during hospitalization, cognition, number of falls during hospitalization, complications and length of hospital stay in days.

—

Contacts

Public ContactSjanne Bosman

intern postadres: AA-43, Kamer Z3.16

s.bosman@umcg.nl050- 36113464

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)