Sleep Interventions for Sleep Disorders

Overseen By Terry E Goldberg, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York State Psychiatric Institute

Must not be taking: Antidepressants, Benzodiazepines

Disqualifiers: Stroke, Neurologic disease, Untreated diabetes, others

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

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help older adults with mild memory issues and sleep problems improve their sleep and brain health. Participants will either receive Cognitive Behavioral Therapy for Insomnia (CBTI) through weekly online sessions or use a headband device to enhance sleep waves (Acoustic Slow-Wave Activity Enhancement). The researchers aim to assess how these treatments affect memory and daily cognitive functions over six months. Good candidates are those over 60 who struggle with insomnia and have mild memory issues but do not have severe sleep disorders or take certain medications regularly. As an unphased trial, this study offers participants the chance to explore innovative treatments that could enhance their sleep and cognitive health.

Will I have to stop taking my current medications?

If you take sleep medications more than 3 times a week, you cannot join the study. If you take them 3 or fewer times a week, you'll need to stop before the study starts, but this will be done with your doctor's guidance to ensure safety.

What prior data suggests that these sleep interventions are safe for older adults with sleep disorders?

Research shows that both treatments in the trial, Acoustic Slow-Wave Activity Enhancement (SWAE) and Cognitive Behavioral Therapy for Insomnia (CBTI), are safe for people.

Studies indicate that acoustic stimulation, like SWAE, improves sleep quality without the risks associated with sleep medications. It usually causes fewer mood and behavior-related side effects, making it generally well-tolerated.

CBTI is also a safe choice. It has been compared to sleep medications and found to have similar positive effects on sleep. Importantly, CBTI does not cause the side effects often seen with medications. Some people might feel tired or less motivated, but these effects are uncommon.

Both SWAE and CBTI have a strong safety record. They address sleep issues without causing significant harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for sleep disorders because they offer innovative ways to improve sleep quality. Acoustic Slow-Wave Activity Enhancement uses the Dreem2 headband to boost deep sleep through sound waves, which is a novel delivery method compared to traditional medications or therapy. Meanwhile, Cognitive Behavioral Therapy for Insomnia (CBTI) offers a non-drug approach through personalized telehealth sessions, providing flexibility and accessibility for participants. These treatments are distinct because they avoid pharmacological interventions, aiming to enhance natural sleep processes or modify sleep-related behaviors, potentially leading to fewer side effects and a more sustainable impact on sleep health.

What evidence suggests that this trial's treatments could be effective for sleep disorders?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBTI), which participants in this trial may receive, works as well as sleep medications but with fewer side effects. It improves sleep habits and reduces the likelihood of insomnia returning. Studies also suggest that digital CBTI may be more effective than medication for long-term sleep improvement.

For Acoustic Slow-Wave Activity Enhancement (SWAE), another treatment option in this trial, research has found that this method can significantly enhance deep sleep, leading to better sleep quality. This technique is associated with improved cognitive skills and fewer mood issues, offering sleep benefits without the risks linked to sleep medications. ^{2 4 6 7 8}

Who Is on the Research Team?

Hyun Kim, PhD

Principal Investigator

Columbia University/ New York State Psychiatric Institute

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 60-85 with mild cognitive impairment and sleep disturbances. They must score at least 22 on a memory screening, have internet access, and an informant to participate. Excluded are those with certain neurological diseases, untreated diabetes, active cancer treatment, other sleep disorders besides insomnia, severe psychiatric conditions or depression.

Inclusion Criteria

I do not use sleep medications more than 3 times a week.

Telephone MMSE (T-MMSE) score of 22 or greater at screening assessment; T-MMSE <18 during post-treatment visit or 6-month follow-up will be discontinued from participation of the study

Individuals with aMCI, as determined by the Wechsler Memory Scale-Revised Logical Memory Delayed Recall (LM) and Quick Dementia Rating Scale (QDRS)

Exclusion Criteria

I have been diagnosed with a psychiatric condition like schizophrenia, bipolar disorder, or a substance use disorder.

I have had a stroke or am at high risk for heart disease.

I have a neurological condition like MS, epilepsy, or had a significant head injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cognitive behavioral therapy for insomnia (CBTI) or acoustic slow-wave activity enhancement (SWAE) over 6 months

24 weeks

8 weekly telehealth sessions for CBTI; nightly use of Dreem2 headband for SWAE

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acoustic Slow-Wave Activity Enhancement
• Cognitive Behavioral Therapy for Insomnia

Trial Overview

The study tests two sleep treatments: Cognitive Behavioral Therapy for Insomnia (CBTI) and Acoustic Slow-Wave Activity Enhancement (SWAE). Participants will be randomly assigned to one of these interventions and monitored over six months to see how the treatments affect their brain function and daily living skills.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy for Insomnia Active Control 1 Intervention

Participants assigned to the CBTI treatment group will receive 8 weeks of weekly telehealth sessions with a masters-level therapist. Each session is approximately 50 minutes in duration.

Group II: Acoustic Slow-Wave Activity Enhancement Active Control 1 Intervention

Participants assigned to the SWAE group will be instructed to use the Dreem2 headband at least four nights out of seven nights of the week.

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

A randomized controlled trial involving 101 adult patients with insomnia disorder found that fully automated digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) was significantly less effective than individual face-to-face Cognitive Behavioral Therapy for Insomnia (FtF CBT-I) in reducing insomnia severity at both 9 and 33 weeks, with dCBT-I showing inferior results.

At week 33, the mean difference in insomnia severity scores indicated that dCBT-I did not meet the non-inferiority criteria compared to FtF CBT-I, suggesting that while dCBT-I is a viable option, it may not be as effective as traditional therapy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy. Kallestad, H., Scott, J., Vedaa, Ø., et al.[2023]

A smartphone-based, culturally adapted digital cognitive behavioral therapy for insomnia (DCBT-I) significantly reduced insomnia severity compared to sleep education in a randomized trial with 82 participants over 6 weeks.

Participants in the DCBT-I group experienced greater improvements in total sleep time and sleep efficiency at both 3 and 6 months follow-up, indicating its efficacy in enhancing sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. Zhang, C., Liu, Y., Guo, X., et al.[2023]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in adults with chronic insomnia, with these benefits sustained up to 48 weeks after treatment.

dCBT also reduces the use of both prescription and non-prescription sleep medications compared to sleep hygiene education, indicating its effectiveness in managing insomnia without relying heavily on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. Luik, AI., Marsden, A., Emsley, R., et al.[2021]

A network meta-analysis of 54 randomized controlled trials with 11,815 participants found that web-based cognitive behavioral therapy for insomnia (CBTi) with a therapist significantly improves total sleep time, reduces sleep onset latency, and decreases wake after sleep onset compared to usual care.

Web-based CBTi with therapists was ranked as the most effective treatment for insomnia, indicating it is the optimal intervention for enhancing sleep duration and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of digital cognitive behavioral therapy for insomnia: A systematic review and network meta-analysis. Hasan, F., Tu, YK., Yang, CM., et al.[2022]

Digital Cognitive Behavioral Therapy (dCBT) has been shown to be effective in treating insomnia across various populations, with benefits extending to overall well-being.

There are three types of dCBT—supportive, guided, and fully automated—each differing in clinician involvement and scalability, but more research is needed to explore cost-effectiveness and implementation challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy (dCBT) for Insomnia: a State-of-the-Science Review. Luik, AI., Kyle, SD., Espie, CA.[2020]

In a study involving 1720 adults with insomnia, digital cognitive behavioral therapy for insomnia (dCBT-I) significantly reduced intraindividual variability in sleep metrics, particularly in sleep onset latency, which is crucial for improving sleep quality.

The reduction in variability in sleep metrics was found to mediate significant improvements in both insomnia severity and psychological distress, highlighting the effectiveness of dCBT-I as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. Vestergaard, CL., Vedaa, Ø., Simpson, MR., et al.[2021]

The Veterans Health Administration developed a digital mental health intervention called Path to Better Sleep (PTBS) to provide accessible cognitive behavioral therapy for insomnia (CBT-I) to veterans, addressing the shortage of trained providers.

Feedback from veteran and spouse evaluation panels significantly influenced the design of PTBS, leading to improvements in user engagement by emphasizing CBT-I efficacy, simplifying content, and incorporating relatable veteran testimonials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Evaluation Panels During the Development of a Digital Intervention for Veterans Based on Cognitive Behavioral Therapy for Insomnia: Qualitative Evaluation Study. Ryan, AT., Brenner, LA., Ulmer, CS., et al.[2023]

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