Acoustic slow-wave activity enhancement / Sleep Disturbance / Cognitive behavioral therapy for insomnia · Interventional Study

Sleep Interventions and Neurocognitive Outcomes

ClinicalTrials.gov · August 3, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned pilot randomized trial comparing cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE) in older adults with amnestic mild cognitive impairment and sleep disturbance. No results are available; the trial has not yet begun recruitment and is registered prospectively to evaluate effects on cognition and everyday functioning over 24 weeks.

What was studied

Interventional, Randomized, Parallel, Open label, Treatment purpose. Sleep Disturbance, Amnestic Mild Cognitive Impairment; age from 60 Years; to 85 Years. Intervention: Cognitive Behavioral Therapy for Insomnia; Acoustic Slow-Wave Activity Enhancement. Compared with: CBTI versus SWAE (both active interventions). n = 50. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for a planned interventional pilot trial with no results posted; recruitment has not yet begun.

Study design

As stated by the source record.

MethodsPrimary outcome measures: No Practice Effect (NPE) battery (assessed at Baseline, Week 9, Week 24); Everyday Cognition (ECog) (assessed at Baseline, Week 9, Week 24); Conners Continuous Performance Test (CPT-3) (assessed at Baseline, Week 9, Week 24)

DesignInterventional, Randomized, Parallel, Open label, Treatment purpose

PopulationSleep Disturbance, Amnestic Mild Cognitive Impairment; age from 60 Years; to 85 Years

Sample size50

InterventionCognitive Behavioral Therapy for Insomnia; Acoustic Slow-Wave Activity Enhancement

ComparatorCBTI versus SWAE (both active interventions)

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment50

Primary outcome: No Practice Effect batteryBaseline, Week 9, Week 24

Primary outcome: Everyday Cognition (ECog)Baseline, Week 9, Week 24

Primary outcome: Conners Continuous Performance Test (CPT-3)Baseline, Week 9, Week 24

Caveats

Results not yet reported in this registry record; trial has not started recruitment (NOT_YET_RECRUITING status).
Study phase not specified; blinding strategy not disclosed.
Sample size is small (n=50) as a pilot; generalizability limited until results emerge.
Comparator arms are both active interventions; no placebo or standard care control group specified.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized pilot trial with two active treatment arms; phase not specified.

Directness

moderate

Targets amnestic MCI and sleep disturbance; uses validated cognitive batteries.

Consistency

insufficient

No results reported; consistency cannot be assessed at registry stage.

Risk of bias

insufficient

Blinding, allocation concealment, and conduct details not disclosed in registry record.

Sample adequacy

limited

Planned enrollment 50 participants; pilot design with no results yet available.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05987007). This is a study registration, not published results. Lead sponsor: New York State Psychiatric Institute. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Sleep Disturbance, Amnestic Mild Cognitive Impairment. Interventions: DEVICE: Acoustic slow-wave activity enhancement; BEHAVIORAL: Cognitive behavioral therapy for insomnia. Primary outcome measures: No Practice Effect (NPE) battery , Baseline, Week 9, Week 24; Everyday Cognition (ECog) , Baseline, Week 9, Week 24; Conners Continuous Performance Test (CPT-3) , Baseline, Week 9, Week 24. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

New York State Psychiatric InstituteNCT05987007Acoustic slow-wave activity enhancementSleep DisturbanceCognitive behavioral therapy for insomniaAmnestic Mild Cognitive Impairment