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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
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
Secondary ID [1] 285813 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problematic sleep 293714 0
Condition category
Condition code
Other 294013 294013 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Physical Medicine / Rehabilitation 294014 294014 0 0
Other physical medicine / rehabilitation
Alternative and Complementary Medicine 294015 294015 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 290785 0
Treatment: Other
Intervention code [2] 290786 0
Rehabilitation
Comparator / control treatment
Single cohort - repeated case series. No control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293792 0
Total Sleep Time in 24 hours

Average amount of sleep per 24 hours over 7 days of measurement, assessed via actigraph
Timepoint [1] 293792 0
Measured for 7 days immediately following the conclusion of treatment (Week 5)
Primary outcome [2] 293793 0
Total Sleep Time in 24 hours

Average amount of sleep per 24 hours over 7 days of measurement, assessed via sleep diary
Timepoint [2] 293793 0
Recorded for 7 days immediately following the conclusion of treatment (Week 5)
Primary outcome [3] 293794 0
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
Timepoint [3] 293794 0
Measured in the week following treatment (Week 5), pertaining to the prior week
Secondary outcome [1] 311858 0
Longest Sleep Period in 24 hours

Average for longest period over 7 days of measurement, assessed via actigraph
Timepoint [1] 311858 0
Measured for 7 days immediately following the conclusion of treatment (Week 5)
Secondary outcome [2] 311859 0
Longest Self-Regulated Sleep Period in 24 hours

Average for longest period over 7 days of measurement, assessed via sleep diary
Timepoint [2] 311859 0
Recorded for 7 days immediately following the conclusion of treatment (Week 5)
Secondary outcome [3] 311860 0
Longest Wake Period in 24 hours

Average for longest period over 7 days of measurement, assessed via actigraph
Timepoint [3] 311860 0
Measured for 7 days immediately following the conclusion of treatment (Week 5)
Secondary outcome [4] 311861 0
Total Sleep Time during Daytime

Average amount of sleep per 12 hours (7am - 7pm) over 7 days of measurement, assessed via actigraph
Timepoint [4] 311861 0
Measured for 7 days immediately following the conclusion of treatment (Week 5)
Secondary outcome [5] 311862 0
Total Sleep Time during Daytime

Average amount of sleep per 12 hours (7am - 7pm) over 7 days of measurement, assessed via sleep diary
Timepoint [5] 311862 0
Recorded for 7 days immediately following the conclusion of treatment (Week 5)
Secondary outcome [6] 311863 0
Number of Daytime Naps

Average number of naps per 12 hours (7am - 7pm) over 7 days of measurement, assessed via actigraph
Timepoint [6] 311863 0
Measured for 7 days immediately following the conclusion of treatment (Week 5)
Secondary outcome [7] 311864 0
Number of Daytime Naps

Average number of naps per 12 hours (7am - 7pm) over 7 days of measurement, assessed via sleep diary
Timepoint [7] 311864 0
Recorded for 7 days immediately following the conclusion of treatment (Week 5)
Secondary outcome [8] 311865 0
Total Sleep Time during Nighttime

Average amount of sleep per 12 hours (7pm - 7am) over 7 days of measurement, assessed via actigraph
Timepoint [8] 311865 0
Measured for 7 days immediately following the conclusion of treatment (Week 5)
Secondary outcome [9] 311866 0
Total Sleep Time during Nighttime

Average amount of sleep per 12 hours (7pm - 7am) over 7 days of measurement, assessed via sleep diary
Timepoint [9] 311866 0
Recorded for 7 days immediately following the conclusion of treatment (Week 5)
Secondary outcome [10] 311867 0
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
Timepoint [10] 311867 0
Measured in the week following treatment (Week 5), pertaining to the prior week
Secondary outcome [11] 311868 0
Number of Nighttime Wakes

Average number of wakes per 12 hours (7pm - 7am) over 7 days of measurement, assessed via actigraph
Timepoint [11] 311868 0
Measured for 7 days immediately following the conclusion of treatment (Week 5)
Secondary outcome [12] 311869 0
Number of Nighttime Wakes

Average number of wakes per 12 hours (7pm - 7am) over 7 days of measurement, assessed via sleep diary
Timepoint [12] 311869 0
Recorded for 7 days immediately following the conclusion of treatment (Week 5)
Secondary outcome [13] 311870 0
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
Timepoint [13] 311870 0
Measured in the week following treatment (Week 5), pertaining to the prior week

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.
Minimum age
4 Months
Maximum age
12 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.



Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable - case series.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable - case series.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6516 0
New Zealand
State/province [1] 6516 0
Auckland region

Funding & Sponsors
Funding source category [1] 290375 0
University
Name [1] 290375 0
Unitec Institute of Technology
Address [1] 290375 0
Private Bag 92025
Victoria Street West
Auckland 1142
Country [1] 290375 0
New Zealand
Primary sponsor type
Individual
Name
Catherine J. Bacon
Address
Osteopathy, Department of Community and Health Services
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 289101 0
None
Name [1] 289101 0
Address [1] 289101 0
Country [1] 289101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292077 0
Unitec Research Ethics Committee
Ethics committee address [1] 292077 0
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Ethics committee country [1] 292077 0
New Zealand
Date submitted for ethics approval [1] 292077 0
Approval date [1] 292077 0
23/08/2012
Ethics approval number [1] 292077 0
2012-1074
Ethics committee name [2] 292078 0
New Zealand Plunket Ethics Committee
Ethics committee address [2] 292078 0
New Zealand Plunket
40 Mercer Street
Wellington 6011
Ethics committee country [2] 292078 0
New Zealand
Date submitted for ethics approval [2] 292078 0
Approval date [2] 292078 0
30/08/2012
Ethics approval number [2] 292078 0
No reference number provided

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53374 0
Dr Catherine J. Bacon
Address 53374 0
Department of Community and Health Services: Osteopathy Division
Unitec Institute of Technology
Private Bag 92025 Victoria Street West
Auckland 1142
Country 53374 0
New Zealand
Phone 53374 0
+64 9 815 6794
Fax 53374 0
Email 53374 0
cbacon@unitec.ac.nz
Contact person for public queries
Name 53375 0
Dr Catherine Bacon
Address 53375 0
Department of Community and Health Services: Osteopathy Division
Unitec Institute of Technology
Private Bag 92025 Victoria Street West
Auckland 1142
Country 53375 0
New Zealand
Phone 53375 0
+64 9 815 6794
Fax 53375 0
Email 53375 0
cbacon@unitec.ac.nz
Contact person for scientific queries
Name 53376 0
Dr Catherine J. Bacon
Address 53376 0
Department of Community and Health Services: Osteopathy Division
Unitec Institute of Technology
Private Bag 92025 Victoria Street West
Auckland 1142
Country 53376 0
New Zealand
Phone 53376 0
+64 9 815 6794
Fax 53376 0
Email 53376 0
cbacon@unitec.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary