Sleep and Circadian Rhythm + Memory Support for Sleep Disorders

Overseen By Allison Harvey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Berkeley

Disqualifiers: Severe sleep apnea, Dementia, Homelessness, Night shift work, Substance abuse, others

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

Compensation: Varies

Number of Visits: 11

Duration: 8-10 weeks

178 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Memory Support Intervention (MSI) for sleep disorders?

Research shows that similar treatments, like the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), have been effective in improving sleep and mental health outcomes. Additionally, interventions targeting sleep in older adults with mild cognitive impairment have shown improvements in sleep quality, which is linked to better cognitive health. ^{1 2 3 4 5}

Is the Sleep and Circadian Rhythm + Memory Support treatment safe for humans?

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) has been studied in community settings, but the available research does not provide specific safety data for humans. Further studies are needed to establish its safety profile. ^{3 4 6 7 8}

How is the Memory Support Intervention treatment different from other treatments for sleep disorders?

The Memory Support Intervention is unique because it targets both sleep and circadian rhythm disruptions, which are linked to memory issues, especially in older adults. This approach is novel as it aims to restore regular circadian rhythms, potentially preventing or slowing neurodegenerative diseases and improving cognitive function. ^{6 9 10 11 12}

What is the purpose of this trial?

Mental illness is often chronic, severe, and difficult to treat. Though there has been significant progress towards establishing effective and efficient interventions for psychological health problems, many individuals do not gain lasting benefits from these treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings from the cognitive science literature to improve treatment outcomes. In this study, the investigators aim to conduct an open trial that includes individuals 50 years and older to assess if a novel version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.

Research Team

Allison G Harvey, PhD

Principal Investigator

University of California, Berkeley

Eligibility Criteria

This trial is for individuals aged 50 and older who speak English, have mobility issues, low income, and show no signs of cognitive impairment. They must be experiencing sleep or circadian disturbances but not severe untreated sleep apnea or other conditions that severely affect sleep. Participants need to consent to communication between researchers and their medical providers.

Inclusion Criteria

Low income

Consent to regular communications between the research team and the patient's medical provider/s if needed to communicate about suicide risk

English language fluency

Exclusion Criteria

Suicide risk sufficient to preclude treatment on an outpatient basis

Night shift work >2 nights per week in the past 3 months

I have severe sleep apnea or moderate sleep apnea with extreme daytime tiredness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive TranS-C+MSI or TranS-C alone in eight 50-minute, weekly, individual sessions

8-10 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

2 visits (in-person) at 6-month and 12-month follow-up

Treatment Details

Interventions

• Memory Support Intervention
• Transdiagnostic Intervention for Sleep and Circadian Dysfunction

Trial Overview The study tests a new Memory Support Intervention (MSI) designed to improve treatment outcomes by enhancing patient memory. It focuses on people with mental illness suffering from sleep disorders and aims to see if MSI can better their sleep patterns, daily functioning, and memory retention.

Participant Groups

Group I: TranS-C+MSI Experimental Treatment 2 Interventions

Transdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention

Group II: TranS-C alone Active Control 1 Intervention

The Transdiagnostic Sleep and Circadian Intervention will be delivered alone

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials

193

Recruited

716,000+

Findings from Research

A six-session cognitive behavioral therapy for insomnia (CBT-I) significantly improved sleep quality in older adults with mild cognitive impairment (MCI), as shown in a study with 28 participants.

The intervention also led to improvements in executive functioning, particularly in tasks related to inhibition, suggesting that better sleep may positively influence cognitive abilities in individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological Functioning in Older Adults with Mild Cognitive Impairment and Insomnia Randomized to CBT-I or Control Group. Cassidy-Eagle, E., Siebern, A., Unti, L., et al.[2022]

The 'Sleep Well, Think Well' (SWTW) intervention significantly improved subjective sleep quality in older adults with mild cognitive impairment (MCI), with a large effect size (Cohen's d = 0.83) based on a study of 35 participants over eight weeks.

While the SWTW program showed promise in reducing daytime sleepiness (Cohen's d = 0.70), it did not significantly impact cognitive functioning, depressive symptoms, or objective sleep measures, indicating that while sleep quality improved, other cognitive outcomes may require different interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sleep Well, Think Well" Group Program for Mild Cognitive Impairment: A Randomized Controlled Pilot Study. Naismith, SL., Pye, J., Terpening, Z., et al.[2020]

The TranS-C intervention, when combined with usual care, significantly reduced functional impairment, psychiatric symptoms, and sleep disturbances in adults with serious mental illness, as shown in a study of 121 participants over 8 weeks.

These improvements were not only significant immediately after treatment but were also largely maintained at a 6-month follow-up, indicating the potential long-term benefits of the TranS-C approach for enhancing sleep and overall functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting. Harvey, AG., Dong, L., Hein, K., et al.[2022]

A 24-week randomized controlled trial will test a personalized chronotherapy intervention, including bright light therapy and tailored physical activity, to improve sleep quality in 96 older adults with mild cognitive impairment (MCI).

Improving sleep quality through this intervention may help maintain cognitive health and reduce the risk of dementia in older adults, addressing a common issue among those with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buying time: a proof-of-concept randomized controlled trial to improve sleep quality and cognitive function among older adults with mild cognitive impairment. Falck, RS., Davis, JC., Best, JR., et al.[2018]

The Transdiagnostic Sleep and Circadian Intervention (TranS-C) improved eveningness circadian preference and some sleep quality measures in adolescents over a 6-month follow-up, compared to Psychoeducation about sleep and health (PE).

However, TranS-C did not significantly reduce risks in five health domains, while PE showed benefits in reducing parent-reported behavioral health risks during the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A transdiagnostic sleep and circadian intervention for adolescents: six-month follow-up of a randomized controlled trial. Dong, L., Dolsen, MR., Martinez, AJ., et al.[2021]

Individuals with mild cognitive impairment (MCI) show significant disruptions in circadian rhythms, such as changes in rest-activity patterns and hormone levels, which are linked to cognitive deficits.

Restoring regular circadian rhythms may offer a promising intervention to prevent or slow the progression of neurodegenerative diseases and improve cognitive function in MCI patients, highlighting the need for further longitudinal studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian Rhythm Changes in Healthy Aging and Mild Cognitive Impairment. Keihani, A., Mayeli, A., Ferrarelli, F.[2023]

In a study of 45 seniors, including 16 with mild cognitive impairment (MCI), it was found that those with amnestic MCI (aMCI) experienced less sleep disturbance compared to those with nonamnestic MCI (naMCI) and cognitively intact individuals, as measured by objective sleep metrics over a 6-month period.

The findings suggest that the type of MCI may influence sleep patterns, with naMCI showing more disturbed sleep than aMCI, indicating potential differences in the underlying pathology of these MCI subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep habits in mild cognitive impairment. Hayes, TL., Riley, T., Mattek, N., et al.[2021]

Participants with serious mental illness who had multiple sleep and circadian problems experienced greater overall impairment and psychiatric symptoms, highlighting the importance of addressing these issues in treatment.

The Transdiagnostic Sleep and Circadian Intervention (TranS-C) combined with usual care led to significant improvements in sleep and psychosocial functioning for various specific sleep problems, demonstrating its effectiveness regardless of the number of sleep issues present.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in a community setting: Unpacking comorbidity. Sarfan, LD., Hilmoe, HE., Gumport, NB., et al.[2021]

Memory performance is influenced by various biological rhythms, including infradian, circadian, and ultradian rhythms, which can affect memory disorders.

Paradoxical sleep, particularly its 90-minute cycles, plays a crucial role in enhancing learning and memory processes, highlighting the importance of sleep patterns in cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronobiological rhythm constraints of memory processes. Leconte, P.[2008]

In a study involving healthy older adults, consistent circadian activity rhythms were found to enhance associative memory performance, regardless of total sleep time or physical activity levels.

The research indicated that hippocampal activity during memory retrieval is positively linked to both memory accuracy and the consistency of circadian rhythms, suggesting that these rhythms could serve as a biomarker for cognitive function in aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hippocampal activity mediates the relationship between circadian activity rhythms and memory in older adults. Sherman, SM., Mumford, JA., Schnyer, DM.[2022]

In a study involving 33 participants (11 with mild cognitive impairment, 11 with mild Alzheimer's disease, and 11 healthy controls), those with mild cognitive impairment and Alzheimer's showed significantly reduced rapid eye movement sleep and cyclic alternating pattern parameters, indicating disrupted sleep architecture.

The findings suggest that decreased sleep instability in individuals with mild cognitive impairment and Alzheimer's disease may serve as a potential biomarker for neurodegeneration, highlighting the link between sleep quality and cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-rapid eye movement sleep instability in mild cognitive impairment: a pilot study. Maestri, M., Carnicelli, L., Tognoni, G., et al.[2016]

Older adults with mild cognitive impairment (MCI) show altered circadian rest/activity rhythms, including greater nighttime activity and reduced morning activity compared to cognitively normal individuals, based on a study of 179 participants.

Certain circadian rhythm metrics, including the novel fPC3 and standard measures like relative amplitude, are linked to better cognitive performance, particularly in episodic memory and executive function, suggesting that sleep patterns may influence cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of actigraphic sleep and circadian rest/activity rhythms with cognition in the early phase of Alzheimer's disease. Alfini, A., Albert, M., Faria, AV., et al.[2023]

References

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

Neuropsychological Functioning in Older Adults with Mild Cognitive Impairment and Insomnia Randomized to CBT-I or Control Group. [2022]

2. England pubmed.ncbi.nlm.nih.gov

"Sleep Well, Think Well" Group Program for Mild Cognitive Impairment: A Randomized Controlled Pilot Study. [2020]

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

A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting. [2022]

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

Buying time: a proof-of-concept randomized controlled trial to improve sleep quality and cognitive function among older adults with mild cognitive impairment. [2018]

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

A transdiagnostic sleep and circadian intervention for adolescents: six-month follow-up of a randomized controlled trial. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Circadian Rhythm Changes in Healthy Aging and Mild Cognitive Impairment. [2023]

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

Sleep habits in mild cognitive impairment. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in a community setting: Unpacking comorbidity. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

Chronobiological rhythm constraints of memory processes. [2008]

10. England pubmed.ncbi.nlm.nih.gov

Hippocampal activity mediates the relationship between circadian activity rhythms and memory in older adults. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Non-rapid eye movement sleep instability in mild cognitive impairment: a pilot study. [2016]

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

Associations of actigraphic sleep and circadian rest/activity rhythms with cognition in the early phase of Alzheimer's disease. [2023]