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Long term effects on sleep quality and adverse effects related to (continued) melatonin use since early childhood.

Long term effects on sleep quality and adverse effects related to (continued) melatonin use since early childhood.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25842
Enrollment
72
Registered
2016-04-04
Start date
2016-05-01
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

CSOI, melatonin, sleep quality

Interventions

Data collection will occur through administration of an electronic, retrospective, self-administered questionnaire. Comprising seven parts, the questionnaire assesses demographics, melatonin therapy s

Sponsors

Faculty of Veterinary Medicine, Pharmacy Department, Utrecht University. In samenwerking met Gelderse Vallei Hospital Ede.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All participants from the MELDOS trial (ISRCTN20033346)

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

MeasureTime frame
Current melatonin therapy status ((dis)continuation of therapy, dose, compliance, drug holidays, rebound sleep disturbance after (temporary) cessation of therapy, reason(s) for cessation or resuming of therapy) and current sleep habits (PSQI and ISI score).

Secondary

MeasureTime frame
Secondary outcomes are chronotype (MEQ score, MSFsc), caffeine consumption, smoking status, use of electronics before bedtime and pubertal development. Furthermore, possible side effects and adverse events will be evaluated.

Contacts

Public ContactI.M. van Geijlswijk

Yalelaan 106

i.m.vangeijlswijk@uu.nl030-2532066

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)