Sleep HygieneNCT05971212
Sleep Support for Children With Neurodevelopmental Disorders
A study testing Behavioural sleep clinic access in people with Sleep Hygiene and Sleep Wake Disorders, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Around 80% of children with neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD) and autism are reported to have significant difficulties with sleep. This may be a problem with settling off to sleep, waking repeatedly in the night, or both. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Sleep Hygiene, Sleep Wake Disorders
- What is being tested?
- Behavioural sleep clinic access
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children to be included will fulfil all of the inclusion criteria.
- Formal diagnosis of ADHD, autism or another neurodevelopmental condition,
- Age 4-11 years,
- Severe sleep disturbance (defined as Score of 3 or more on Composite Sleep Disturbance Index),
- Been taking melatonin to aid sleep onset for more than 12 months
Who cannot join
- Already accessed a sleep clinic at Sheffield Children's Hospital or The Sleep Charity.
- English not first language
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Research Facility, Sheffield Children's Hospital
Sheffield
Heather Elphick, 0114 2717000, h.elphick@nhs.net
About this study
Official title: Can a Supportive Sleep-Practitioner-led Intervention Lead to Improved Sleep, Wellbeing and Reduced Medication Prescribing for Children With Neurodevelopmental Disorders and Co-occurring Severe Sleep Difficulties?
Around 80% of children with neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD) and autism are reported to have significant difficulties with sleep. This may be a problem with settling off to sleep, waking repeatedly in the night, or both.
Often these children will be prescribed a medication called melatonin to help them sleep, but there is no strong evidence of its effectiveness in children, the long-term side effects are not known and prescriptions for this drug cost millions of pounds a year for the NHS. Many children continue to have persistent sleep problems despite taking melatonin. Sleep support programmes delivered by nurses and sleep practitioners are known to be effective and to give parents and young people long-term strategies for promoting sleep without the use of medication. However, sleep support services are not universally funded.
In this feasibility study 76 children with ADHD, autism or other neurodevelopmental disorder who have been prescribed and have been regularly taking melatonin for at least a year but still have severe sleep difficulties will be recruited. The investigators will help to improve the child's sleep with a sleep practitioner support programme and, if possible, reduce the dose of melatonin or stop it completely if it is no longer needed. Using this design, it will be possible to test whether a programme delivered by sleep practitioners will significantly improve sleep for children using a non-medical approach and in turn improve the health and well-being of the child and family and reduce melatonin prescribing, thereby saving NHS resources and the potential for long-term side effects. The study design will be delivered by Sheffield Children's Hospital and supported by parent users, the Sleep Charity and Sheffield CCG. The results will be disseminated widely to local, regional and national groups as well as via social media.
Read the detailed description
Sleep is a restorative process, fundamental to physical and psychological health. Sleep disturbances including bedtime resistance and night-time awakening occur in 80% children with neurodisability, the most common associations being with Attention Deficit Hyperactivity Disorder (ADHD), Autism, cerebral palsy and syndromes such as Down, Prader-Willi and Angelman syndromes. In a meta-analysis of subjective and objective studies found that ADHD is associated with higher bedtime resistance, sleep-onset difficulty and longer latency, night awakenings, trouble waking up in the morning, sleep-disordered breathing, daytime sleepiness, more shifts between sleep stages, lower sleep efficiency and less sleep time. Anxiety and depression symptoms may have a significant role in the prevalence of sleep difficulties which would be clearly observed in bedtime resistance, sleep anxiety, night time awakenings and sleep onset delay. Thus, teaching children how to develop sleep hygiene and the use of behavioural modification to manage their fears would help children to fall asleep easily and reduce bedtime resistance which therefore would improve sleep quantity and quality.
The impact of sleep disturbance on children's health is wide-ranging with sleep deprivation leading to difficulties with mood, psychosocial problems and a detrimental impact on the child's cognitive ability and learning. Parents of children with sleep difficulties can suffer high levels of stress and anxiety, decreased ability to work or to drive safely, relationship and financial problems. These stresses lead to an increased demand on NHS primary care services and to prescriptions of drugs such as antidepressants. Children with significant sleep difficulties in the UK are often treated with melatonin, a hormone playing a key role in the timing of sleep-wake cycle, despite the findings of a recent systematic review that suggest that evidence does not strongly support its use. The drug is costly to the health service, with individual Clinical Commissioning Groups (CCGs) spending up to £500k per year on prescription charges for this drug alone.
Evidence from sleep clinics delivered in the local authority, NHS and voluntary sectors has shown that an intensive sleep support intervention can be highly effective. A recent retrospective evaluation of a nurse-led sleep support service successfully discharged 63% children without melatonin prescriptions after a median of two face-to face visits and three telephone calls. The proposed study will aim to support children with neurodevelopmental problems taking melatonin for sleep difficulties to develop long-term strategies for promoting sleep and to reduce drug prescriptions.
- Conditions
- Sleep Hygiene, Sleep Wake Disorders
- Being tested
- Behavioural sleep clinic access
- Medical subject headings
- Sleep Hygiene, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural sleep clinic accessBehavioural
Access to behavioural Sleep Clinic
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Access to Sleep Clinic immediately Receives: Behavioral: Behavioural sleep clinic access |
| Control | Experimental | Access to Sleep Clinic delayed Receives: Behavioral: Behavioural sleep clinic access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Diary
7 day sleep diary (parent report)
Measured: 20 weeks
Actiwatch data
Actiwatch worn for a 7 day period
Measured: 20 weeks
Child Sleep Habits Questionnaire (CSHQ)
Child Sleep Habits Questionnaire (CSHQ)
Measured: 20 weeks
Melatonin Prescription Status
Questionnaire (designed by researchers) asking about patient dosage and type of melatonin taken
Measured: 20 weeks
Secondary outcomes (4)
Strengths and Difficulties Questionnaire (SDQ)
Strengths and Difficulties Questionnaire (SDQ)
Measured: 20 weeks
CHU-9D Quality of Life questionnaire
CHU-9D Quality of Life questionnaire
Measured: 20 weeks
Healthcare Utilisation
Questionnaire (designed by researchers) recording how many times patient has accessed healthcare settings/professionals in last year
Measured: 20 weeks
Parent Wellbeing
Warwick- Edinburgh Mental Wellbeing Scale
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start29 Jan 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Elphick, Study director, Sheffield Children's NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971212
- Sponsor's protocol ID
- SCH-2530
- Status last verified
- Jul 2023
- First submitted
- 6 Jun 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Supportive Sleep-Practitioner-led Intervention Lead to Improved Sleep, Wellbeing and Reduced Medication Prescribing for Children With Neurodevelopmental Disorders and Co-occurring Severe Sleep Difficulties?
- ClinicalTrials.gov ID
- NCT05971212
- Acronym / sponsor ID
- SCH-2530
- Conditions
- Sleep Hygiene, Sleep Wake Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Around 80% of children with neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD) and autism are reported to have significant difficulties with sleep. This may be a problem with settling off to sleep, waking repeatedly in the night, or both.
Often these children will be prescribed a medication called melatonin to help them sleep, but there is no strong evidence of its effectiveness in children, the long-term side effects are not known and prescriptions for this drug cost millions of pounds a year for the NHS. Many children continue to have persistent sleep problems despite taking melatonin. Sleep support programmes delivered by nurses and sleep practitioners are known to be effective and to give parents and young people long-term strategies for promoting sleep without the use of medication. However, sleep support services are not universally funded.
In this feasibility study 76 children with ADHD, autism or other neurodevelopmental disorder who have been prescribed and have been regularly taking melatonin for at least a year but still have severe sleep difficulties will be recruited. The investigators will help to improve the child's sleep with a sleep practitioner support programme and, if possible, reduce the dose of melatonin or stop it completely if it is no longer needed. Using this design, it will be possible to test whether a programme delivered by sleep practitioners will significantly improve sleep for children using a non-medical approach and in turn improve the health and well-being of the child and family and reduce melatonin prescribing, thereby saving NHS resources and the potential for long-term side effects. The study design will be delivered by Sheffield Children's Hospital and supported by parent users, the Sleep Charity and Sheffield CCG. The results will be disseminated widely to local, regional and national groups as well as via social media.
Detailed description
Sleep is a restorative process, fundamental to physical and psychological health. Sleep disturbances including bedtime resistance and night-time awakening occur in 80% children with neurodisability, the most common associations being with Attention Deficit Hyperactivity Disorder (ADHD), Autism, cerebral palsy and syndromes such as Down, Prader-Willi and Angelman syndromes. In a meta-analysis of subjective and objective studies found that ADHD is associated with higher bedtime resistance, sleep-onset difficulty and longer latency, night awakenings, trouble waking up in the morning, sleep-disordered breathing, daytime sleepiness, more shifts between sleep stages, lower sleep efficiency and less sleep time. Anxiety and depression symptoms may have a significant role in the prevalence of sleep difficulties which would be clearly observed in bedtime resistance, sleep anxiety, night time awakenings and sleep onset delay. Thus, teaching children how to develop sleep hygiene and the use of behavioural modification to manage their fears would help children to fall asleep easily and reduce bedtime resistance which therefore would improve sleep quantity and quality.
The impact of sleep disturbance on children's health is wide-ranging with sleep deprivation leading to difficulties with mood, psychosocial problems and a detrimental impact on the child's cognitive ability and learning. Parents of children with sleep difficulties can suffer high levels of stress and anxiety, decreased ability to work or to drive safely, relationship and financial problems. These stresses lead to an increased demand on NHS primary care services and to prescriptions of drugs such as antidepressants. Children with significant sleep difficulties in the UK are often treated with melatonin, a hormone playing a key role in the timing of sleep-wake cycle, despite the findings of a recent systematic review that suggest that evidence does not strongly support its use. The drug is costly to the health service, with individual Clinical Commissioning Groups (CCGs) spending up to £500k per year on prescription charges for this drug alone.
Evidence from sleep clinics delivered in the local authority, NHS and voluntary sectors has shown that an intensive sleep support intervention can be highly effective. A recent retrospective evaluation of a nurse-led sleep support service successfully discharged 63% children without melatonin prescriptions after a median of two face-to face visits and three telephone calls. The proposed study will aim to support children with neurodevelopmental problems taking melatonin for sleep difficulties to develop long-term strategies for promoting sleep and to reduce drug prescriptions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Behavioural sleep clinic accessAccess to Sleep Clinic immediately |
| Control | Experimental | Behavioral: Behavioural sleep clinic accessAccess to Sleep Clinic delayed |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children to be included will fulfil all of the inclusion criteria.
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural sleep clinic accessAccess to behavioural Sleep Clinic | Behavioural | Control, Intervention |
Primary outcome
Sleep Diary
Time frame: 20 weeks
7 day sleep diary (parent report)
Actiwatch data
Time frame: 20 weeks
Actiwatch worn for a 7 day period
Child Sleep Habits Questionnaire (CSHQ)
Time frame: 20 weeks
Child Sleep Habits Questionnaire (CSHQ)
Melatonin Prescription Status
Time frame: 20 weeks
Questionnaire (designed by researchers) asking about patient dosage and type of melatonin taken
4 secondary outcomes
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 20 weeks
CHU-9D Quality of Life questionnaire
Time frame: 20 weeks
Healthcare Utilisation
Time frame: 20 weeks
Parent Wellbeing
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Elphick study director
Sheffield Children's NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural sleep clinic access in people with Sleep Hygiene and Sleep Wake Disorders, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Elphick (01142 717000, h.elphick@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Diary (time frame: 20 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.