- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06926036
Micromanaging Human Sleep Physiology to Treat Sleep Apnea and Other Disorders
This study will examine whether a combination of breathing training during wake and targeted reactivation of the training during sleep can induce breathing changes during sleep and subsequent cognitive benefits during wake.
Participants with obstructive sleep apnea (who have not yet been treated for sleep apnea) will be recruited. Participants will engage in breath training for one week in their own homes and to record their sleep at home using commercially available mobile devices and subsequently have their sleep monitored for one night of polysomnography recordings plus targeted reactivation in a laboratory setting.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ken A Paller, PhD
- Phone Number: 847-467-3370
- Email: kap@northwestern.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Contact:
- Ken A Paller, PhD
- Phone Number: 847-467-3370
- Email: kap@northwestern.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Right-handed, English-speaking adults, 18-60 years old who report normal hearing during sleep
- Participants with suspected obstructive sleep apnea (OSA) (including those who have been diagnosed by a physician and those whose self-reported symptoms of OSA on the STOP-BANG questionnaire classify them as being "individuals with intermediate to high risk".
- No report of any other sleep disorder besides OSA.
- No report of any neurological or cardiometabolic diseases or disorders.
- Not currently under active treatment for sleep apnea.
- BMI ≤ 40.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All participants
|
In this within-participant design, all participants will undergo the same intervention of waking training and TMR. Waking training - waking training will associate an auditory cue with a specific learned behavioral response (a tongue protrusion and inhalation) during daily sessions for approximately one week, with home sleep monitoring. TMR - Targeted memory reactivation (TMR) refers to the process of playing learning-associated audio cues quietly during sleep in order to reactivate memories associated with the cue. After completion of waking training, TMR occurs in a laboratory setting, with PSG recording, during a single night. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Apnea-Hypopnea Index (AHI)
Time Frame: Day 1
|
AHI indexes the severity of OSA on the night of the study.
|
Day 1
|
|
Respiratory event duration
Time Frame: Day 1
|
The duration of a hypopnea or apnea on the night of the study.
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ken A Paller, PhD, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP00002577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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