Sleep Restriction Therapy for Autism and Sleep Disorders

Overseen By Robin Libove, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Severe psychiatric disorder, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 3 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness and manageability of sleep restriction therapy for children with autism who have sleep problems. The treatment involves parents learning to manage their child's sleep through weekly telehealth sessions. The trial suits children diagnosed with autism who live in California and have ongoing sleep disturbances but are otherwise stable in their current treatments. Parents must participate in the sessions and speak English.

As an unphased trial, this study offers families a unique opportunity to contribute to understanding and improving sleep therapies for children with autism.

Will I have to stop taking my current medications?

The trial requires that participants have stable medications for at least 2 weeks and no planned changes in their treatments during the study. So, you should not stop taking your current medications if they are stable.

What prior data suggests that sleep restriction therapy is safe for children with autism and sleep disorders?

Research has shown that sleep restriction therapy can improve sleep problems in children with autism spectrum disorder (ASD). Although few studies specifically address its safety, this therapy is generally safe because it involves changing sleep schedules rather than using medication.

One source noted that more thorough studies are needed to fully understand the short- and long-term safety of sleep restriction therapy in children with ASD. While more information is necessary, current knowledge suggests it is well-tolerated since it mainly involves changing behaviors instead of medical treatments.

In summary, although more detailed studies are needed, sleep restriction therapy is generally considered safe as it focuses on adjusting sleep patterns without using drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Sleep Restriction Therapy is unique because it focuses on changing sleep patterns rather than using medication, which is a common approach for managing sleep disorders in individuals with autism. Unlike typical treatments that might involve sedatives or behavioral therapies, this method involves a structured schedule to limit and then gradually increase sleep time, helping to regulate the body's natural sleep cycle. Researchers are excited about this technique because it could offer a non-pharmacological option that empowers individuals and their families to manage sleep without the potential side effects of medication. Additionally, the use of telehealth sessions makes it accessible and convenient for participants, providing support without needing in-person visits.

What evidence suggests that sleep restriction therapy is effective for sleep problems in children with autism?

Studies have shown that sleep restriction therapy can help with sleep problems, especially insomnia, in the short term. Over 80% of people with autism experience sleep issues, making effective treatments crucial. This trial will evaluate sleep restriction therapy, which research suggests can help children with autism fall asleep faster. This therapy limits time spent in bed to increase sleepiness and improve sleep quality. Although more research is needed, early results are promising for managing sleep disorders in children with autism. ^{1 3 6 7 8}

Who Is on the Research Team?

Emma K Baker, MPsych(Clin), PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children with Autism Spectrum Disorder (ASD) who are experiencing sleep problems. Parents will be trained to deliver the therapy via a secure telemedicine platform.

Inclusion Criteria

Stable on medications for at least 2 weeks

Diagnosed with autism spectrum disorder based on history and review of available medical records

I have been diagnosed with sleep problems.

Exclusion Criteria

My child currently has seizures or epilepsy.

Parent or child diagnosed with severe psychiatric disorder or unstable medical problem

Primary sleep disorder is a circadian rhythm sleep-wake disorder as determined by the sleep interview and Children's ChronoType Questionnaire.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sleep restriction therapy delivered via telehealth sessions once per week for three weeks, with parent-training in delivering the intervention.

3 weeks

3 visits (virtual)

Follow-up

Participants implement sleep restriction therapy and are monitored for safety and effectiveness during a follow-up period.

4 weeks

4 weeks of monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Restriction Therapy

Trial Overview The study is testing Sleep Restriction Therapy (SRT) to see if it's acceptable, tolerable, and effective for improving sleep in children with ASD.

How Is the Trial Designed?

Group I: Sleep Restriction Therapy Experimental Treatment 1 Intervention

Participants attend telehealth sessions once per week for three weeks and implement sleep restriction therapy in between sessions and for 4 weeks during a follow-up period.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A pilot study involving 17 children with autism and insomnia showed that an 8-session cognitive behavioral treatment for childhood insomnia (CBT-CI) significantly improved both child and parent sleep, as well as reduced challenging behaviors like irritability and hyperactivity.

Parents reported that CBT-CI was helpful and suitable for their children, indicating that this treatment is feasible and promising for addressing insomnia in school-aged children with autism, warranting further research through randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral treatment of insomnia in school-aged children with autism spectrum disorder: A pilot feasibility study. McCrae, CS., Chan, WS., Curtis, AF., et al.[2020]

In a 14-week study involving 24 children with autism spectrum disorders, supplemental melatonin significantly improved sleep onset latency, showing effectiveness as early as the first week and maintaining benefits over several months.

The treatment was well tolerated and safe, leading to improvements not only in sleep but also in behavior and parenting stress, supporting the potential for larger randomized trials in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes. Malow, B., Adkins, KW., McGrew, SG., et al.[2022]

This study will be the first to evaluate cognitive behavioral treatment for childhood insomnia (CBT-CI) specifically adapted for children with autism spectrum disorder (ASD) and insomnia, involving 180 participants aged 6-12 years.

The trial aims to assess the effectiveness of CBT-CI in reducing insomnia and its negative impacts on children with ASD, with outcomes measured at multiple time points, including sleep quality, daytime functioning, and parental stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for targeting insomnia in school-aged children with autism spectrum disorder without intellectual disability: a randomised control trial. McCrae, CS., Mazurek, MO., Curtis, AF., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06627205

Study Details | NCT06627205 | Sleep Restriction Therapy ... This outcome measure will determine the effectiveness of sleep restriction therapy in improving sleep disturbances in children with autism spectrum disorder.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079221000782

The clinical effects of sleep restriction therapy for insomnia Sleep restriction therapy effectively improves insomnia severity and sleep continuity in the short term; more studies are needed to assess if effects are ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11046719/

Sleep and Autism: Current Research, Clinical Assessment ... Autism spectrum disorder is associated with a high rate of sleep problems, affecting over 80% of autistic individuals.

4. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-10-2024-7f9df

Sleep Restriction Therapy for Autism and Sleep Disorders In a 14-week study involving 24 children with autism spectrum disorders, supplemental melatonin significantly improved sleep onset latency, showing ...

5. trialx.com trialx.com/clinical-trials/listings/298186/sleep-restriction-therapy-srt-for-sleep-problems-in-children-with-autism/

Sleep Restriction Therapy (SRT) for Sleep Problems in ... The purpose of this open label trial is to examine the acceptability, tolerability, and feasibility and preliminary effectiveness of sleep restriction therapy.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945723003106

Sleep disturbances in subjects with autism spectrum disorder Only in a low percentage of individuals with ASD sleep disturbances tend to disappear over time, with a remission rate of 8.3%, compared to a remission rate of ...

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000009033

Treatment for insomnia and disrupted sleep behavior in ... To review pharmacologic and nonpharmacologic strategies for treating sleep disturbances in children and adolescents with autism spectrum disorder (ASD) and ...

8. mdpi.com mdpi.com/2076-3425/15/9/983

Sleep Disorders in Children with Autism Spectrum Disorder Robust RCTs are needed to establish short- and long-term efficacy and safety, especially in children with ASD and comorbid sleep disturbances [125]. 7 ...