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Trial registered on ANZCTR
Registration number
ACTRN12615000003572
Ethics application status
Approved
Date submitted
9/12/2014
Date registered
7/01/2015
Date last updated
16/01/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Sleep in the Family: Effect of osteopathic manual therapy on sleep patterns of 4 - 12 month old infants described as problematic sleepers
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Scientific title
The effect of osteopathic manual therapy on sleep patterns of first-born infants from 4 - 12 months of age with parent-perceived problematic sleep
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Secondary ID [1]
285813
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Problematic sleep
293714
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Condition category
Condition code
Other
294013
294013
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0
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Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Physical Medicine / Rehabilitation
294014
294014
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0
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Other physical medicine / rehabilitation
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Alternative and Complementary Medicine
294015
294015
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Osteopathic manual therapy was administered by qualified, experienced, NZ registered osteopaths. Therapy entailed four weekly semi-structured 30-minute osteopathy treatments and consisted of a selection of techniques applied at the discretion of the practitioner. Technique choice was limited to those suitable for use on infants, including structural, visceral, cranial and rhythmic techniques.
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Intervention code [1]
290785
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Treatment: Other
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Intervention code [2]
290786
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Rehabilitation
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Comparator / control treatment
Single cohort - repeated case series. No control.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Total Sleep Time in 24 hours
Average amount of sleep per 24 hours over 7 days of measurement, assessed via actigraph
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Assessment method [1]
293792
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Timepoint [1]
293792
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Measured for 7 days immediately following the conclusion of treatment (Week 5)
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Primary outcome [2]
293793
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Total Sleep Time in 24 hours
Average amount of sleep per 24 hours over 7 days of measurement, assessed via sleep diary
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Assessment method [2]
293793
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Timepoint [2]
293793
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Recorded for 7 days immediately following the conclusion of treatment (Week 5)
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Primary outcome [3]
293794
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Total Sleep Time during Daytime
Average amount of sleep per 12 hours (7am - 7pm) estimated for the previous 7 days, assessed via Brief Infant Sleep Questionnaire
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Assessment method [3]
293794
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Timepoint [3]
293794
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Measured in the week following treatment (Week 5), pertaining to the prior week
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Secondary outcome [1]
311858
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Longest Sleep Period in 24 hours
Average for longest period over 7 days of measurement, assessed via actigraph
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Assessment method [1]
311858
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Timepoint [1]
311858
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Measured for 7 days immediately following the conclusion of treatment (Week 5)
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Secondary outcome [2]
311859
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Longest Self-Regulated Sleep Period in 24 hours
Average for longest period over 7 days of measurement, assessed via sleep diary
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Assessment method [2]
311859
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Timepoint [2]
311859
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Recorded for 7 days immediately following the conclusion of treatment (Week 5)
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Secondary outcome [3]
311860
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Longest Wake Period in 24 hours
Average for longest period over 7 days of measurement, assessed via actigraph
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Assessment method [3]
311860
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Timepoint [3]
311860
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Measured for 7 days immediately following the conclusion of treatment (Week 5)
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Secondary outcome [4]
311861
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Total Sleep Time during Daytime
Average amount of sleep per 12 hours (7am - 7pm) over 7 days of measurement, assessed via actigraph
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Assessment method [4]
311861
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Timepoint [4]
311861
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Measured for 7 days immediately following the conclusion of treatment (Week 5)
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Secondary outcome [5]
311862
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Total Sleep Time during Daytime
Average amount of sleep per 12 hours (7am - 7pm) over 7 days of measurement, assessed via sleep diary
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Assessment method [5]
311862
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Timepoint [5]
311862
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Recorded for 7 days immediately following the conclusion of treatment (Week 5)
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Secondary outcome [6]
311863
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Number of Daytime Naps
Average number of naps per 12 hours (7am - 7pm) over 7 days of measurement, assessed via actigraph
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Assessment method [6]
311863
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Timepoint [6]
311863
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Measured for 7 days immediately following the conclusion of treatment (Week 5)
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Secondary outcome [7]
311864
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Number of Daytime Naps
Average number of naps per 12 hours (7am - 7pm) over 7 days of measurement, assessed via sleep diary
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Assessment method [7]
311864
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Timepoint [7]
311864
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Recorded for 7 days immediately following the conclusion of treatment (Week 5)
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Secondary outcome [8]
311865
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Total Sleep Time during Nighttime
Average amount of sleep per 12 hours (7pm - 7am) over 7 days of measurement, assessed via actigraph
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Assessment method [8]
311865
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Timepoint [8]
311865
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Measured for 7 days immediately following the conclusion of treatment (Week 5)
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Secondary outcome [9]
311866
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Total Sleep Time during Nighttime
Average amount of sleep per 12 hours (7pm - 7am) over 7 days of measurement, assessed via sleep diary
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Assessment method [9]
311866
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Timepoint [9]
311866
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Recorded for 7 days immediately following the conclusion of treatment (Week 5)
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Secondary outcome [10]
311867
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Total Sleep Time during Nighttime
Average amount of sleep per 12 hours (7pm - 7am) estimated for the previous 7 days, assessed via Brief Infant Sleep Questionnaire
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Assessment method [10]
311867
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Timepoint [10]
311867
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Measured in the week following treatment (Week 5), pertaining to the prior week
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Secondary outcome [11]
311868
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Number of Nighttime Wakes
Average number of wakes per 12 hours (7pm - 7am) over 7 days of measurement, assessed via actigraph
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Assessment method [11]
311868
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Timepoint [11]
311868
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Measured for 7 days immediately following the conclusion of treatment (Week 5)
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Secondary outcome [12]
311869
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Number of Nighttime Wakes
Average number of wakes per 12 hours (7pm - 7am) over 7 days of measurement, assessed via sleep diary
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Assessment method [12]
311869
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Timepoint [12]
311869
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Recorded for 7 days immediately following the conclusion of treatment (Week 5)
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Secondary outcome [13]
311870
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Number of Nighttime Wakes
Average amount of sleep per 12 hours (7pm - 7am) estimated for the previous 7 days, assessed via Brief Infant Sleep Questionnaire
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Assessment method [13]
311870
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Timepoint [13]
311870
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Measured in the week following treatment (Week 5), pertaining to the prior week
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Eligibility
Key inclusion criteria
Infant with two adult parents, described by at least one parent as a problematic sleeper, and with no other children under 5 years or other adults with a caregiving role living in the premises.
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Minimum age
4
Months
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Maximum age
12
Months
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Currently undergoing manual therapy treatment
Previously received manual therapy treatment for sleep issues
Taking medication
Diagnosed with serious medical condition,e.g. recurrent infections, asthma, obstructive apnoea.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable - case series.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable - case series.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
As this was a novel, preliminary assessment of the efficacy of osteopathic manual therapy for treatment of infants, for which there are minimal previous data, a repeated case-series approach was taken.
Four case studies were examined to provide pilot data about the possible efficacy of this treatment.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2013
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Actual
20/03/2013
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Date of last participant enrolment
Anticipated
31/05/2013
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Actual
14/05/2013
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Date of last data collection
Anticipated
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Actual
20/06/2013
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Sample size
Target
4
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Accrual to date
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Final
4
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Recruitment outside Australia
Country [1]
6516
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New Zealand
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State/province [1]
6516
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Auckland region
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Funding & Sponsors
Funding source category [1]
290375
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University
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Name [1]
290375
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Unitec Institute of Technology
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Address [1]
290375
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Private Bag 92025
Victoria Street West
Auckland 1142
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Country [1]
290375
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New Zealand
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Primary sponsor type
Individual
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Name
Catherine J. Bacon
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Address
Osteopathy, Department of Community and Health Services
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
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Country
New Zealand
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Secondary sponsor category [1]
289101
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None
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Name [1]
289101
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Address [1]
289101
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Country [1]
289101
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
292077
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Unitec Research Ethics Committee
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Ethics committee address [1]
292077
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Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
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Ethics committee country [1]
292077
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New Zealand
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Date submitted for ethics approval [1]
292077
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Approval date [1]
292077
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23/08/2012
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Ethics approval number [1]
292077
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2012-1074
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Ethics committee name [2]
292078
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New Zealand Plunket Ethics Committee
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Ethics committee address [2]
292078
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New Zealand Plunket
40 Mercer Street
Wellington 6011
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Ethics committee country [2]
292078
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New Zealand
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Date submitted for ethics approval [2]
292078
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Approval date [2]
292078
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30/08/2012
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Ethics approval number [2]
292078
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No reference number provided
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Summary
Brief summary
This case-series report of an intervention into the efficacy of osteopathic manual therapy (OMT) is a substudy of a study aimed at describing sleep patterns of infants and their parents. The aim of this interventional study was to assess the effectiveness of osteopathic manual therapy (OMT) on infants between 4 - 12 months of age who were described by their parents as problematic sleepers. It is anecdotally reported that OMT may help improve problematic infant sleep. Sleep was measured using actigraphy, parentally completed sleep diaries and the Brief Infant Sleep Questionnaire. Measures included the total amount of sleep time (over 24 hours, daytime and night-time), longest sleep period, longest self regulated sleep period, night time wakes and daytime naps.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
53374
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Dr Catherine J. Bacon
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Address
53374
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Department of Community and Health Services: Osteopathy Division
Unitec Institute of Technology
Private Bag 92025 Victoria Street West
Auckland 1142
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Country
53374
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New Zealand
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Phone
53374
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+64 9 815 6794
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Fax
53374
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Email
53374
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[email protected]
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Contact person for public queries
Name
53375
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Dr Catherine Bacon
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Address
53375
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Department of Community and Health Services: Osteopathy Division
Unitec Institute of Technology
Private Bag 92025 Victoria Street West
Auckland 1142
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Country
53375
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New Zealand
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Phone
53375
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+64 9 815 6794
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Fax
53375
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Email
53375
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[email protected]
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Contact person for scientific queries
Name
53376
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Dr Catherine J. Bacon
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Address
53376
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Department of Community and Health Services: Osteopathy Division
Unitec Institute of Technology
Private Bag 92025 Victoria Street West
Auckland 1142
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Country
53376
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New Zealand
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Phone
53376
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+64 9 815 6794
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Fax
53376
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Email
53376
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF