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

Not Applicable

Completed

• Conditions: cerebral palsy; thermoregulation; sleep disturbance; activity, participation and quality of life; Physical Medicine / Rehabilitation - Occupational therapy; Neurological - Other neurological disorders

• Registration Number: ACTRN12614000647639
• Lead Sponsor: Edith Cowan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Child variation in distal and proximal skin temperature, measured using Thermochron iButtons[Measured continuously from one hour before bedtime to wake time, for four consecutive nights.];Child variation in sleep/wake patterns, measured using Actigraph sensors and sleep log.[Measured continuously day and night, for four consecutive days/nights.];Child: Quality of Life, measured using CPQoL Questionnaire.[Measured at beginning of the first bedding phase, and at the end of each of the two bedding phases (ie, three time points).]

Secondary Outcome Measures

Name	Time	Method
Child core body temperature, measured using infra red tympanic membrane thermometer.[Measured one hour before bedtime, at bedtime and on morning waking, for four consecutive nights.];Child: goals for activity and participation, measured using Canadian Occupational Performance Measure with Goal Attainment Scale.[Measured at the beginning of the first bedding phase and at the end of both bedding phases (three time points).];Caregiver sleep and quality of life; measured using Pittsburgh Sleep Quality Index and Iowa Fatigue Scale[Measured at the beginning of the fist bedding phase, and at the end of both bedding phases (three time points).];Child thermal comfort, measured using thermal comfort report chart[Measured one hour before bed, at bedtime and on waking for four consecutive nights.]