Comparing the Side-lying Sleep Positioning to Back-lying in Infants With Cleft Palate (SLUMBRS2)

August 30, 2023 updated by: Manchester University NHS Foundation Trust

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

The craniofacial abnormalities found in infants and children with cleft palate (CP) lead to increased risk of obstructive sleep apnoea (OSA). In children and adults sleep position is known to influence the patency of the airway during sleep. Altering sleep position in infants with CP may offer a 'low-cost, high impact' intervention to limit the negative impacts of OSA on child development.

Children with CP are at increased risk of impairment in learning, memory and cognition, with OSA representing an additional risk to cognitive development. Infants with CP are at risk of poor weight gain and 'failure to thrive', which can be further exacerbated by co-existing OSA.

The design and conduct of the proposed randomised controlled trial will benefit from lessons learned from both the feasibility and other previous studies. Investigators demonstrated that existing advice given about sleep position varied significantly with some centres recommending back-lying and others side-lying. Sample size calculations were based on this multi-source data. Parents in the feasibility study knew that sleep position advice for infants with CP changes regularly. They understood why not adhering to 'national guidance' (DoH 2009, Back to Sleep) could be necessary as their infants are "different to normal infants".

How will this study benefit infants with cleft palate and their parents? The proposed study will eliminate the current uncertainty and variability in advice provided to parents of infants with CP, whilst potentially limiting the negative impact of OSA on development. This work has been prioritised and received unanimous support from Cleft Lip and Palate Association (CLAPA), Craniofacial Society Great Britain and Ireland (CFSGBI) and Clinical Nurse Specialists. Aim.To determine the clinical effectiveness in infants with CP of side-lying as compared to back-lying sleep positioning in reducing oxygen desaturation resulting from OSA.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary aim of this project is to determine the clinical effectiveness in infants with cleft palate (CP) of side-lying as compared to back-lying sleep positioning in reducing oxygen desaturation resulting from obstructive sleep apnoea (OSA). This will be achieved:

  • comparing oxygen saturation during sleep in the side- and back-lying positions at 1 month of age.
  • comparing sleep quality between the side-lying and back-lying groups using a parental questionnaire.
  • co-developing national recommendations with parents regarding sleep position for infants with CP.

A randomised controlled trial (RCT) of side-lying compared with back-lying sleep positioning in reducing oxygen desaturation resulting from OSA in infants with CP. The design and conduct of the study will benefit from lessons learned from the feasibility and other previous studies. All parents in the feasibility study indicated strong interest to participate in further studies evaluating the effects of sleep position. Infants meeting the eligibility criteria will be randomised to side-lying or back-lying in a ratio 1:1 using a minimisation routine incorporating a random element to reduce predictability. Minimisation factors will be clinical site and syndrome suspected or indicated (yes / no). Allocations will be delivered via a password-protected web-based system. The allocated position will only be used on the day(s) when the infant is monitored for the study purposes. Thereafter, parents will be free to revert back to the standard sleep position as advised by their cleft centre, should it be different than that used for the monitoring period. All centres represented at the preparatory meeting with the United Kingdom (UK) Lead Clinical Nurse Specialist group, confirmed that the side-lying position was recommended in some infants at their centre, irrespective of whether it was the standard advice used. As such, all centres had experience of the side-lying position. It was decided not to change the specific advice that centres give to parents regarding how to position the infant in a side-lying position, but any standard written or verbal information would be collected by the study documents.

An internal pilot will investigate participants' opinions about their participation in the study. Using bespoke questionnaires participants' experience will be assessed and it will be decided how it could be improved. After 6 months questionnaire results will be analysed and if necessary study amendments will be put in place to reflect participants' opinions.

Data from the feasibility study and published studies have reported estimates of the standard deviation (SD) of the primary outcome ODI-4 in the side-lying infants at four weeks to range from 8 to 11 units, with a higher SD observed in the back-lying group. The observed difference in mean ODI-4 between the side-lying and back-lying infant cohorts was 15 units (a standardised effect size of 0.91). Investigators considered a smaller but more realistic difference in means of five units to be a clinically important difference (SD 10), a standardised effect size of 0.5. The sample size calculation comparing two means with unequal variances for the primary outcome was, therefore, based on a standardised effect size of 0.5. To account for potential unequal variances in each group a variance ratio of 2 was used in the calculations. To detect a difference of 0.5 standard deviation score (SDS) with 80% power and alpha equal to 0.05 would require 96 infants to be monitored in each arm of the trial (a total of 192 participants). Informed by the multicentre feasibility and oximetry studies the sample size will be inflated to 244 participants in the RCT, to allow for potential attrition of 21%.

This will follow a pre-specified and approved statistical analysis plan. The primary analysis of the RCT data will use intention-to-treat. Baseline data will be analysed to assess the comparability of the demographic and clinical characteristics of the participants. Data from the trial arms will be compared using generalised linear models and adjusted for minimisation covariates where appropriate. Estimates of treatment effect size will be reported as differences in means for continuous outcomes, and risk ratios for dichotomous outcomes and reported along with 95% confidence intervals. Subgroup analyses will explore the effects of sleep position on infants with and without suspected associated syndromes through subgroup treatment interactions, at a stricter alpha level 0.01.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • Not yet recruiting
        • Birmingham Women's and Children's NHS Foundation Trust
        • Contact:
          • Michelle Jones
      • Bristol, United Kingdom
        • Not yet recruiting
        • University Hospitals Bristol NHS Foundation Trust
        • Contact:
          • Cathy Marsh
      • Cambridge, United Kingdom
        • Not yet recruiting
        • Cambridge University Hospitals NHS Foundation Trust
        • Contact:
          • Melanie Lindup
      • Leeds, United Kingdom
        • Not yet recruiting
        • Leeds Teaching Hospitals NHS Trust
        • Contact:
          • Emma Blair
      • Liverpool, United Kingdom
        • Not yet recruiting
        • Alder Hey Children's NHS Foundation Trust
        • Contact:
          • Helen Robson
      • London, United Kingdom
        • Not yet recruiting
        • Great Ormond Street Hospital for Children NHS Foundation Trust
        • Contact:
          • Helen Moreland
      • Manchester, United Kingdom
        • Recruiting
        • Manchester University NHS Foundation Trust
        • Contact:
          • Helen Robson
      • Newcastle Upon Tyne, United Kingdom
        • Not yet recruiting
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust
        • Contact:
          • Chris Couhig
      • Nottingham, United Kingdom
        • Not yet recruiting
        • Nottingham University Hospitals NHS Trust
        • Contact:
          • Heather Sahunta
      • Salisbury, United Kingdom
        • Not yet recruiting
        • Salisbury Nhs Foundation Trust
        • Contact:
          • Nichola Hudson
      • Swansea, United Kingdom
        • Not yet recruiting
        • Swansea Bay University Local Health Board
        • Contact:
          • Michaela Rowe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 weeks to 1 month (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infants diagnosed with an isolated CP under the care of a collaborating centre
  • Infants who are 3 to 5 weeks of age when monitored
  • Parents willing to give consent and able to complete study procedures

Exclusion Criteria:

  • Infants with associated cleft lip
  • Infants born prematurely (before 37 week gestation or up to and including 36 weeks and 6 days)
  • Infants with cardiorespiratory disease
  • Infants requiring an intervention to assist with breathing (nasopharyngeal airway)
  • Infants requiring an intervention to assist with feeding (nasogastric tube)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Back lying sleep position
sleep on the back
Other: back sleep positioning
sleeping on the back.
Experimental: Side lying sleep position
sleep on the side
Other: side sleep positioning
sleeping on the side

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oxygen saturation during sleep at 1 month of age
Time Frame: 1 month of age
Oxygen saturation during sleep at 1 month of age (expressed as 4% oxygen desaturation index, ODI-4). Oximetry is considered the mainstay of assessment of oxygenation in infants and will be the primary outcome measurement instrument. The ODI-4 represents the average number of times that oxygen saturation falls by at least 4% from baseline every hour.
1 month of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SPO2 mean
Time Frame: completed at 1 month
mean oxygen saturation
completed at 1 month
SPO2 nadir
Time Frame: completed at 1 month
nadir oxygen saturation
completed at 1 month
Total sleep time
Time Frame: completed at 1 month.
the proportion of total sleep time (TST) with oxygen saturation below: 97%, 95%, 90% and 80%
completed at 1 month.
Oxygen saturation during sleep at 1 month of age
Time Frame: 1 month of age
Oxygen saturation during sleep at 1 month of age (expressed as 3% oxygen desaturation index, ODI-3). Oximetry is considered the mainstay of assessment of oxygenation in infants and will be the primary outcome measurement instrument. The ODI-3 represents the average number of times that oxygen saturation falls by at least 3% from baseline every hour.
1 month of age
Weight
Time Frame: completed at 1 month.
child's weight
completed at 1 month.
Length
Time Frame: 1 month of age
participant's length
1 month of age
Head circumference
Time Frame: 1 month of age
participant's head circumference
1 month of age
Number of participants with Adverse events.
Time Frame: From consent for up to 2 weeks
Number of participants experiencing Adverse events during the trial
From consent for up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Manchester University NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University College, London
University Hospital Southampton NHS Foundation Trust
University of Manchester
National Institute for Health Research, United Kingdom
Salisbury NHS Foundation Trust
Centre for Trials Research, Cardiff University
Cleft Lip and Palate Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Iain Bruce, Prof, Manchester University NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B00785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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