Study protocol for randomised clinical trial comparing the effectiveness of side-lying sleep positioning to back-lying at reducing oxygen desaturation resulting from obstructive sleep apnoea in infants with cleft palate (SLUMBRS2)
Study protocol for randomised clinical trial comparing the effectiveness of side-lying sleep positioning to back-lying at reducing oxygen desaturation resulting from obstructive sleep apnoea in infants with cleft palate (SLUMBRS2)
Introduction: the craniofacial abnormalities found in infants with cleft palate (CP) decrease their airway patency and increase their risk of obstructive sleep apnoea (OSA). We hypothesise that optimising sleep position in infants with CP may improve airway patency and offer a 'low-cost, high-impact' intervention to prevent the negative impacts of OSA. Because cleft centres give inconsistent advice about sleep position: some recommend back-lying and others side-lying, we will compare these in a randomised controlled trial.
Methods and analysis: the aim is to determine the clinical effectiveness of side-lying as compared with back-lying sleep positioning in terms of reducing oxygen desaturation resulting from OSA in 244 infants aged 3-5 weeks of age, diagnosed with an isolated CP in/by UK cleft centres. Primary outcome is the 4% Oxygen Desaturation Index measured using pulse oximetry during sleep.
Research plan: 1. multicentre randomised controlled trial of side-lying compared with back-lying sleep positioning in reducing oxygen desaturation resulting from OSA in infants with CP at one month of age. 2. Internal pilot questionnaire-based study to support parents and clinicians regarding study participation, seeking to identify and address any barriers to recruitment. Monitoring data from the internal pilot will be used in the final analysis. 3. Co-development of new UK recommendations with Cleft Lip and Palate Association (CLAPA) regarding sleep position for infants with CP.
Ethics and dissemination: the study protocol has received the favourable opinion of the West Midlands-South Birmingham Research Ethics Committee. Study results will be published on affiliated webpages and in peer-reviewed publications and conference contributions.
Trial registration number: NCT04478201.
Cleft Lip/complications, Cleft Palate/complications, Humans, Infant, Infant, Newborn, Oxygen, Randomized Controlled Trials as Topic, Sleep, Sleep Apnea, Obstructive
Metryka, Aleksandra
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Cuniffe, Claire
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Evans, Hazel J.
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Gavlak, Johanna G.
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Hudson, Nichola
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Kirby, Nigel
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Lakhanpaul, Monica
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Lin, Yin-Ling
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Murray, Clare
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Rajai, Azita
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Robson, Helen
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Schilder, Anne
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Walsh, Tanya
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Bruce, Iain
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7 April 2021
Metryka, Aleksandra
994fd577-48d9-4ef5-9b41-5ca744379a4b
Cuniffe, Claire
a1166a65-dbfc-493b-a8e3-a2f5a7ded9c8
Evans, Hazel J.
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Gavlak, Johanna G.
c3ff36dc-6562-474c-a6b2-9cbf3b76a4c7
Hudson, Nichola
316b724a-1d6c-4291-8dc5-a4cf56534a7e
Kirby, Nigel
f096d265-c00e-42e0-8cd8-fb5ab470f513
Lakhanpaul, Monica
d102fc4a-7e9f-4172-a4dc-d2cccc050a72
Lin, Yin-Ling
48f50493-9396-42ab-b3c5-181c5dbd5698
Murray, Clare
afa681f7-2a47-417e-b379-02cdf695e3ae
Rajai, Azita
dc629f21-f692-48af-8356-8efef0dde179
Robson, Helen
85f0817d-8fba-4f82-b081-1b94ce11303d
Schilder, Anne
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Walsh, Tanya
75fc72d0-b7fc-4fd8-8ed8-7ed16e891750
Bruce, Iain
34e3b04a-a5a3-44d9-8198-88e443872627
Metryka, Aleksandra, Cuniffe, Claire, Evans, Hazel J., Gavlak, Johanna G., Hudson, Nichola, Kirby, Nigel, Lakhanpaul, Monica, Lin, Yin-Ling, Murray, Clare, Rajai, Azita, Robson, Helen, Schilder, Anne, Walsh, Tanya and Bruce, Iain
(2021)
Study protocol for randomised clinical trial comparing the effectiveness of side-lying sleep positioning to back-lying at reducing oxygen desaturation resulting from obstructive sleep apnoea in infants with cleft palate (SLUMBRS2).
BMJ Open, 11 (4), [e049290].
(doi:10.1136/bmjopen-2021-049290).
Abstract
Introduction: the craniofacial abnormalities found in infants with cleft palate (CP) decrease their airway patency and increase their risk of obstructive sleep apnoea (OSA). We hypothesise that optimising sleep position in infants with CP may improve airway patency and offer a 'low-cost, high-impact' intervention to prevent the negative impacts of OSA. Because cleft centres give inconsistent advice about sleep position: some recommend back-lying and others side-lying, we will compare these in a randomised controlled trial.
Methods and analysis: the aim is to determine the clinical effectiveness of side-lying as compared with back-lying sleep positioning in terms of reducing oxygen desaturation resulting from OSA in 244 infants aged 3-5 weeks of age, diagnosed with an isolated CP in/by UK cleft centres. Primary outcome is the 4% Oxygen Desaturation Index measured using pulse oximetry during sleep.
Research plan: 1. multicentre randomised controlled trial of side-lying compared with back-lying sleep positioning in reducing oxygen desaturation resulting from OSA in infants with CP at one month of age. 2. Internal pilot questionnaire-based study to support parents and clinicians regarding study participation, seeking to identify and address any barriers to recruitment. Monitoring data from the internal pilot will be used in the final analysis. 3. Co-development of new UK recommendations with Cleft Lip and Palate Association (CLAPA) regarding sleep position for infants with CP.
Ethics and dissemination: the study protocol has received the favourable opinion of the West Midlands-South Birmingham Research Ethics Committee. Study results will be published on affiliated webpages and in peer-reviewed publications and conference contributions.
Trial registration number: NCT04478201.
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Accepted/In Press date: 17 March 2021
e-pub ahead of print date: 7 April 2021
Published date: 7 April 2021
Keywords:
Cleft Lip/complications, Cleft Palate/complications, Humans, Infant, Infant, Newborn, Oxygen, Randomized Controlled Trials as Topic, Sleep, Sleep Apnea, Obstructive
Identifiers
Local EPrints ID: 485137
URI: http://eprints.soton.ac.uk/id/eprint/485137
ISSN: 2044-6055
PURE UUID: b5d96ace-4023-4291-a8c0-1d98dee502f5
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Date deposited: 30 Nov 2023 17:34
Last modified: 16 Apr 2024 01:54
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Contributors
Author:
Aleksandra Metryka
Author:
Claire Cuniffe
Author:
Hazel J. Evans
Author:
Johanna G. Gavlak
Author:
Nichola Hudson
Author:
Nigel Kirby
Author:
Monica Lakhanpaul
Author:
Yin-Ling Lin
Author:
Clare Murray
Author:
Azita Rajai
Author:
Helen Robson
Author:
Anne Schilder
Author:
Tanya Walsh
Author:
Iain Bruce
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