Sleep Interventions for Sleep Disorders

Recruiting in New York (>99 mi)

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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This protocol focuses on the effect of sleep interventions on improving sleep and building cognitive/brain resilience in older adults with amnestic mild cognitive impairment and sleep disturbance. Two sleep interventions, cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE), will be utilized in a pilot randomized clinical trial in which participants are randomized to different treatment groups (CBTI or SWAE). Participants will be assessed over a 6-month period in order to examine the impact of sleep treatments on neuropsychological outcomes and cognitively mediated everyday functioning.

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 data supports the effectiveness of the treatment Acoustic Slow-Wave Activity Enhancement, Cognitive Behavioral Therapy for Insomnia, CBT-I, Digital CBT-I, dCBT-I for sleep disorders?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is as effective as sleep medications in the short term and more effective in the long term for improving sleep quality. Digital CBT-I (dCBT-I) has also been found to significantly improve sleep duration, reduce the time it takes to fall asleep, and enhance overall sleep efficiency. ^{1 2 3 4 5}

Is digital cognitive behavioral therapy for insomnia safe for humans?

Digital cognitive behavioral therapy for insomnia (dCBT-I) has been studied in several trials and is generally considered safe for humans, with no significant safety concerns reported in the research. ^{2 6 7 8 9}

How is the treatment Acoustic Slow-Wave Activity Enhancement and Cognitive Behavioral Therapy for Insomnia (CBT-I) different from other treatments for sleep disorders?

This treatment is unique because it combines Acoustic Slow-Wave Activity Enhancement, which uses sound to improve deep sleep, with Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-drug approach that addresses the thoughts and behaviors affecting sleep. Unlike medications, CBT-I has long-term benefits and can be delivered digitally, making it more accessible. ^{1 7 10 11 12}

Research Team

Hyun Kim, PhD

Principal Investigator

Columbia University/ New York State Psychiatric Institute

Eligibility Criteria

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.

I am between 60 and 85 years old and speak English.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of cognitive behavioural therapy for insomnia on sleep architecture and sleep EEG power spectra in psychophysiological insomnia. [2018]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of the Insomnia Coach Mobile App to Assess Its Feasibility, Acceptability, and Potential Efficacy. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of Digital Insomnia Treatment with Adjunctive Wearable Technology: A Pilot Randomized Controlled Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy of digital cognitive behavioral therapy for insomnia: A systematic review and network meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effects of digital cognitive behavioural therapy for insomnia on insomnia severity: a large-scale randomised controlled trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy (dCBT) for Insomnia: a State-of-the-Science Review. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. [2021]

10. United States 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. [2023]

12. Canada 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. [2023]