Identification of cut points for sleep disturbances in a validated measure for children with life-limiting conditions

Identification of cut points for sleep disturbances in a validated measure for children with life-limiting conditions - ICUS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011884

Enrollment

110

Registered

2017-03-21

Start date

2017-04-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Children and adolescents with life-limiting conditions and severe psychomotor impairment along with impaired communication

Interventions

Group 1: Parents of children with life-limiting conditions complete the SNAKE (sleep questionnaire for children with severe motor impairment, "Schlaffragebogen für Kinder mit neurologischen und andere

Eligibility

Sex/Gender

All

Age

1 Years to 25 Years

Inclusion criteria

Inclusion criteria: Children and adolescents with life-limiting conditions and severe psychomotor impairment, planned duration of inpatient stay more than 10 days, parents: Comprehensive understanding of the German language, informed consent

Exclusion criteria

Exclusion criteria: Life expectancy <4 weeks

Design outcomes

Primary

Measure	Time frame
Identification of cut points for SNAKE (first aim); hereto parents complete the SNAKE during their child´s inpatient stay; based on the observation of the patient (first 10 days after admission) an interdisciplinary expert group will deliver an consensus about the existence of sleep disturbances („gold standard“); data analysis: ROC analysis with the index test „SNAKE“ and the reference test „expert consensus“	—

Measure

Time frame

Identification of cut points for SNAKE (first aim); hereto parents complete the SNAKE during their child´s inpatient stay; based on the observation of the patient (first 10 days after admission) an interdisciplinary expert group will deliver an consensus about the existence of sleep disturbances („gold standard“); data analysis: ROC analysis with the index test „SNAKE“ and the reference test „expert consensus“

—

Secondary

Measure	Time frame
Testing des SNAKE´s sensitivity to change archieved by a clinical intervention (second aim) and definition of clinically relevant changes (third aim); hereto follow-up assessment 3 weeks after discharge; data analysis: Paired t-test for differences between SNAKE scores before and after the children´s inpatient stay (second aim) and ROC analysis with index test „change in SNAKE“ and reference test „parents´overall impression of change in their children´s sleep disturbance)	—

Measure

Time frame

Testing des SNAKE´s sensitivity to change archieved by a clinical intervention (second aim) and definition of clinically relevant changes (third aim); hereto follow-up assessment 3 weeks after discharge; data analysis: Paired t-test for differences between SNAKE scores before and after the children´s inpatient stay (second aim) and ROC analysis with index test „change in SNAKE“ and reference test „parents´overall impression of change in their children´s sleep disturbance)

—

Countries

Germany

Contacts

Public ContactLarissa Alice Dreier

Vestische Kinder- und Jugendklinik Datteln, Universität Witten/Herdecke, Lehrstuhl für Kinderschmerztherapie und Pädiatrische Palliativmedizin

l.dreier@kinderpalliativzentrum.de+49 (0)2363975196

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026