Effects and Management of Nocturnal Body Temperature in Children with Cerebral Palsy.

In children with cerebral palsy and reported nocturnal thermoregulation difficulties, is thermoregulation bedding comprising undersheet, oversheet and pillowcover, more effective than sham bedding in improving the child's body temperature, thermal comfort, sleep, activity, participation and quality of life?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000647639

Enrollment

Registered

2014-06-18

Start date

2016-04-04

Completion date

2017-07-17

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Children with Cerebral Palsy (CP) have complex sleep issues and a higher incidence of sleep disturbance than typically developing children. Sleep disturbance has serious impact on their physical and mental health, development, daytime function and well-being, and that of their caregivers. Although management of body temperature is frequently identified as an issue affecting sleep of children with CP, there is no reported information to guide clinical practice in this area. The primary purpose of this research is to determine the effects of thermoregulation materials which are used to manage body temperature during sleep of children with CP. This study will measure the effects of specialised bedding on thermoregulation during sleep of children with CP and will be conducted as an intervention study. In a cross over randomised design, children with CP who have sleep and thermoregulation problems will be randomly assigned to begin a four week trial period using either the intervention bedding or the control (sham bedding). This will be followed by an immediate reversed sham or thermoregulation intervention period for four weeks. Measures of body temperature, thermal comfort, perspiration, and sleep, will be taken during each phase. Measures of children’s and caregivers’ activity, participation and quality of life will be taken at the start and at the end of each phase.

Interventions

Thermoregulation bedding (under sheet, over sheet, pillow cover) made of Outlast thermoregulation fabric, with cotton cover; to be used every night for 4 consecutive weeks. Activity logs, kept by parent or caregiver, will be used to monitor adherence to use of this intervention. There will be a wash out period of one week, with the child using their own, usual bedding, between use of the intervention bedding and the sham bedding.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

6 Years to 17 Years

Healthy volunteers

Inclusion criteria

Children will be included in the study if they: 1. have a diagnosis of cerebral palsy 2. have difficulty every night with thermoregulation during sleep (self report, or noted by caregiver to appear too hot, too sweaty) 3. are expected to sleep in their usual bed for 5/7 nights for 8 consecutive weeks 4. are expected to sleep in their usual bed for 4 consecutive nights (Monday to Thursday) in Week 2 and Week 5 of the study period

Exclusion criteria

Children will be excluded from the study if they 1.have a current infection or illness such as ear infection, chest infection, cold or flu 2. have epilepsy that is not controlled by medication, or 3. are very restless during sleep, and are considered likely to rub their skin (in case of losing an iButton skin temperature logger)

Outcome results