InsomniaSLEEP-AID ITNCT06403969
Sleep in Children With Autism and Intellectual Disability
A study testing Applied Behavior Analysis in people with Insomnia and Autism, run by Värmland County Council, Sweden.
Trial summary
Purposes: Establish proof-of-concept for home polysomnography in the assessment of sleep disorders among prepubertal school children with autism and intellectual disabilities combined; To explore the diagnostic yield of polysomnography for these individuals; To examine the feasibility and treatment effect of Applied… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Insomnia, Autism, Intellectual Disability
- What is being tested?
- Applied Behavior Analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 14 May 2024to 30 Jun 2026
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Insomnia AND
- Autism AND
- Intellectual Disability.
Who cannot join
- Started puberty OR
- Epilepsy OR
- Ongoing melatonin treatment OR
- Obstructive sleep apnea
Trial locations and contacts
No sites are listed yet.
About this study
Official title: SLEEP - in Children With Autism and Intellectual Disability: Investigation and Treatment
Purposes: Establish proof-of-concept for home polysomnography in the assessment of sleep disorders among prepubertal school children with autism and intellectual disabilities combined; To explore the diagnostic yield of polysomnography for these individuals; To examine the feasibility and treatment effect of Applied Behavior Analysis (ABA) for insomnia, focusing on sleep maintenance difficulties, in these children.
Method: Single-case experimental design with multiple baselines and with multiple participants, with a focus on feasibility. N=15 prepubertal children, aged 6-12 years, with autism and intellectual disabilities combined, and difficulties in maintaining nighttime sleep. Assessment with home polysomnography + actigraphy. Intervention with ABA, including functional analysis, measurable goals, and behavior modification based on the functional analysis. Outcome measures from actigraphy and sleep diary with multiple data points at baseline and after treatment. Feasibility is examined as adherence to assessment and treatment, as well as in a qualitative study of parental experiences.
Read the detailed description
Pilot study with a feasibility focus using a single-case experimental design, employing multiple baselines and involving multiple participants. Children aged 6-12 with autism and intellectual disabilities, along with sleep maintenance difficulties, are recruited. Following diagnostic assessment of insomnia, up to two weeks of sleep registration using sleep diaries and actigraphy is initiated. Polysomnography will be used to identify, characterize, and map out the sleep disorder. Registration is conducted at home over one night and supplemented with a home visit. If no significant physiological explanations are discovered, treatment with Applied Behavior Analysis (ABA) conducted by a psychologist is then commenced. The intervention begins with goal formulation. Subsequently, a functional analysis is carried out to analyze the underlying function of a behavior contributing to and maintaining the sleep disorder. This assessment follows the ABC model and is based on clinical interviews, observations, sleep diaries, and actigraphy. Next, a treatment plan with measurable goals and strategies to achieve them is formulated. Interventions are based on both antecedents and consequences, with a strong emphasis on positive reinforcement of favorable sleep behaviors. Overall, the intervention is individualized, and most treatment components from cognitive behavioral therapy may be relevant. Examples include education in sleep hygiene, changes in the sleep environment, and positive reinforcement of favorable behaviors. Stimulus control techniques, such as going to bed when tired and establishing good bedtime routines with visual support, are included. Sleep restriction, limiting naps, and bedtime fading are also part of the intervention. Modified extinction techniques with parental presence may be applied, especially if co-sleeping is problematic, gradually phasing out immediate parental presence in or near the bed while remaining responsive to the child's need for security, with a clear intention to cease co-sleeping. The intervention continues until treatment goals are achieved or for a maximum of eight sessions (up to 60 minutes each) spread over a maximum of eight weeks. Sleep diaries are continued daily throughout the study period, including up to two weeks after the intervention ends. Actigraphy registration is restarted one week after the intervention ends and continues for the same duration as during the baseline registration. Sleep diaries are also recorded in the same manner for a follow-up three months after the intervention ends.
Primary outcomes are change from baseline to follow up one week after completed intervention, regarding Total Sleep Time (TST), Wakefulness After Sleep Onset (WASO), and frequency of night-time awakenings, based on actigraphy. Secondary outcomes are change from baseline to follow up regarding TST, WASO, night-time awakenings and sleep efficiency, based on sleep diaries. Specified outcome is also feasibility of investigation and intervention, as below.
Feasibility of the sleep assessment, including polysomnography, is evaluated in terms of frequency and proportion of completed assessments, as well as parental acceptance of the assessment in the qualitative component below. Method adaptation needs are described. The diagnostic yield of the assessment is reported, patient by patient, and summarized with a hypothesis-generating approach. Parents' experiences of the intervention and its feasibility are qualitatively explored and described. The interview is semi-structured, conducted one month after the intervention ends, and analyzed using qualitative content analysis. Feasibility of the ABA intervention is also evaluated in terms of frequency of completed treatments, therapist ratings of families' adherence to treatment, intervention duration, and therapists' adherence to the study protocol.
- Conditions
- Insomnia, Autism, Intellectual Disability
- Being tested
- Applied Behavior Analysis
- Keywords
- applied behavior analysis, polysomnography, insomnia, autism
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Autistic Disorder, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied Behavior AnalysisBehavioural
Applied Behavior Analysis focusing on nocturnal awakenings. It starts with identification of target behaviors and goals. A functional analysis is conducted to analyze the underlying function of a behavior in connection to the problem. A treatment plan is formulated, including strategies to achieve the goals, and methods to evaluate. Families receive education sleep hygiene. Adaptations focus on antecedents and consequences, with an emphasis on positive reinforcement of favorable behaviors. Various components of Cognitive Behavioral Therapy may be applicable. These include changes in sleep environment, stimulus control, bedtime routines with visual support and prompting. Sleep restriction and bedtime fading are included. Modified extinction techniques with parental presence can be applied, gradually phasing out parental immediate presence. The intervention continues until goals are achieved or for a maximum of 8 sessions (each lasting up to 60 minutes) spread over 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Single case experimental arm | Experimental | ABA intervention with multiple baselines and follow up measurements Receives: Behavioral: Applied Behavior Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
Change from baseline to follow up regarding Total Sleep Time (TST), based on actigraphy.
Measured: One week after completed intervention,
Wakefulness After Sleep Onset
Change from baseline to follow up regarding Wakefulness After Sleep Onset (WASO) based on actigraphy
Measured: One week after completed intervention,
Night time awakenings
Change from baseline to follow up regarding Night time awakenings based on actigraphy
Measured: One week after completed intervention,
Secondary outcomes (3)
Sleep diary measures of Total Sleep Time
Change from baseline to follow up regarding Total Sleep Time (TST), based on sleep diaries.
Measured: One week after completed intervention
Sleep diary measures of Wakefulness After Sleep Onset
Change from baseline to follow up regarding Wakefulness After Sleep Onset (WASO) based on sleep diary
Measured: One week after completed intervention
Sleep diary measures of Night time awakenings
Change from baseline to follow up regarding nighttime awakenings based on sleep diary
Measured: One week after completed intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start14 May 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Case Experimental Design
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Värmland County Council, Sweden
- Sponsor type
- Other government
- Collaborators
- Uppsala University, Uppsala County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Sverre Wikström, Principal investigator, Region Värmland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403969
- Sponsor's protocol ID
- 281174
- Acronym
- SLEEP-AID IT
- Status last verified
- May 2024
- First submitted
- 10 Apr 2024
- Last updated
- 8 May 2024
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLEEP - in Children With Autism and Intellectual Disability: Investigation and Treatment
- ClinicalTrials.gov ID
- NCT06403969
- Acronym / sponsor ID
- SLEEP-AID IT / 281174
- Conditions
- Insomnia, Autism, Intellectual Disability
- Keywords
- applied behavior analysis, polysomnography, insomnia, autism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Värmland County Council, SwedenOther government
- Collaborators
- Uppsala University, Uppsala County Council, Sweden
- Study start
- 14 May 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 May 2024 (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.
Purposes: Establish proof-of-concept for home polysomnography in the assessment of sleep disorders among prepubertal school children with autism and intellectual disabilities combined; To explore the diagnostic yield of polysomnography for these individuals; To examine the feasibility and treatment effect of Applied Behavior Analysis (ABA) for insomnia, focusing on sleep maintenance difficulties, in these children.
Method: Single-case experimental design with multiple baselines and with multiple participants, with a focus on feasibility. N=15 prepubertal children, aged 6-12 years, with autism and intellectual disabilities combined, and difficulties in maintaining nighttime sleep. Assessment with home polysomnography + actigraphy. Intervention with ABA, including functional analysis, measurable goals, and behavior modification based on the functional analysis. Outcome measures from actigraphy and sleep diary with multiple data points at baseline and after treatment. Feasibility is examined as adherence to assessment and treatment, as well as in a qualitative study of parental experiences.
Detailed description
Pilot study with a feasibility focus using a single-case experimental design, employing multiple baselines and involving multiple participants. Children aged 6-12 with autism and intellectual disabilities, along with sleep maintenance difficulties, are recruited. Following diagnostic assessment of insomnia, up to two weeks of sleep registration using sleep diaries and actigraphy is initiated. Polysomnography will be used to identify, characterize, and map out the sleep disorder. Registration is conducted at home over one night and supplemented with a home visit. If no significant physiological explanations are discovered, treatment with Applied Behavior Analysis (ABA) conducted by a psychologist is then commenced. The intervention begins with goal formulation. Subsequently, a functional analysis is carried out to analyze the underlying function of a behavior contributing to and maintaining the sleep disorder. This assessment follows the ABC model and is based on clinical interviews, observations, sleep diaries, and actigraphy. Next, a treatment plan with measurable goals and strategies to achieve them is formulated. Interventions are based on both antecedents and consequences, with a strong emphasis on positive reinforcement of favorable sleep behaviors. Overall, the intervention is individualized, and most treatment components from cognitive behavioral therapy may be relevant. Examples include education in sleep hygiene, changes in the sleep environment, and positive reinforcement of favorable behaviors. Stimulus control techniques, such as going to bed when tired and establishing good bedtime routines with visual support, are included. Sleep restriction, limiting naps, and bedtime fading are also part of the intervention. Modified extinction techniques with parental presence may be applied, especially if co-sleeping is problematic, gradually phasing out immediate parental presence in or near the bed while remaining responsive to the child's need for security, with a clear intention to cease co-sleeping. The intervention continues until treatment goals are achieved or for a maximum of eight sessions (up to 60 minutes each) spread over a maximum of eight weeks. Sleep diaries are continued daily throughout the study period, including up to two weeks after the intervention ends. Actigraphy registration is restarted one week after the intervention ends and continues for the same duration as during the baseline registration. Sleep diaries are also recorded in the same manner for a follow-up three months after the intervention ends.
Primary outcomes are change from baseline to follow up one week after completed intervention, regarding Total Sleep Time (TST), Wakefulness After Sleep Onset (WASO), and frequency of night-time awakenings, based on actigraphy. Secondary outcomes are change from baseline to follow up regarding TST, WASO, night-time awakenings and sleep efficiency, based on sleep diaries. Specified outcome is also feasibility of investigation and intervention, as below.
Feasibility of the sleep assessment, including polysomnography, is evaluated in terms of frequency and proportion of completed assessments, as well as parental acceptance of the assessment in the qualitative component below. Method adaptation needs are described. The diagnostic yield of the assessment is reported, patient by patient, and summarized with a hypothesis-generating approach. Parents' experiences of the intervention and its feasibility are qualitatively explored and described. The interview is semi-structured, conducted one month after the intervention ends, and analyzed using qualitative content analysis. Feasibility of the ABA intervention is also evaluated in terms of frequency of completed treatments, therapist ratings of families' adherence to treatment, intervention duration, and therapists' adherence to the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Case Experimental Design
| Arm | Type | Receives |
|---|---|---|
| Single case experimental arm | Experimental | Behavioral: Applied Behavior AnalysisABA intervention with multiple baselines and follow up measurements |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Insomnia AND
- Autism AND
- Intellectual Disability.
Key exclusion criteria (4 listed)
- Started puberty OR
- Epilepsy OR
- Ongoing melatonin treatment OR
- Obstructive sleep apnea
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 |
|---|---|---|
| Applied Behavior AnalysisApplied Behavior Analysis focusing on nocturnal awakenings. It starts with identification of target behaviors and goals. A functional analysis is conducted to analyze the underlying function of a behavior in connection to the problem. A treatment plan is formulated, including strategies to achieve the goals, and methods to evaluate. Families receive education sleep hygiene. Adaptations focus on antecedents and consequences, with an emphasis on positive reinforcement of favorable behaviors. Various components of Cognitive Behavioral Therapy may be applicable. These include changes in sleep environment, stimulus control, bedtime routines with visual support and prompting. Sleep restriction and bedtime fading are included. Modified extinction techniques with parental presence can be applied, gradually phasing out parental immediate presence. The intervention continues until goals are achieved or for a maximum of 8 sessions (each lasting up to 60 minutes) spread over 8 weeks. | Behavioural | Single case experimental arm |
Primary outcome
Total Sleep Time
Time frame: One week after completed intervention,
Change from baseline to follow up regarding Total Sleep Time (TST), based on actigraphy.
Wakefulness After Sleep Onset
Time frame: One week after completed intervention,
Change from baseline to follow up regarding Wakefulness After Sleep Onset (WASO) based on actigraphy
Night time awakenings
Time frame: One week after completed intervention,
Change from baseline to follow up regarding Night time awakenings based on actigraphy
3 secondary outcomes
Sleep diary measures of Total Sleep Time
Time frame: One week after completed intervention
Sleep diary measures of Wakefulness After Sleep Onset
Time frame: One week after completed intervention
Sleep diary measures of Night time awakenings
Time frame: One week after completed intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- 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.
Sverre Wikström principal investigator
Region Värmland
Questions about this trial
What is this clinical trial studying?
A study testing Applied Behavior Analysis in people with Insomnia and Autism, run by Värmland County Council, Sweden.
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 3 inclusion and 4 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Sverre Wikström, Assoc Prof (+46703456327, sverre.wikstrom@regionvarmland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (time frame: One week after completed intervention,). The study lists 3 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 8 May 2024.