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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05089682
Other study ID # 19-001216
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 22, 2021
Est. completion date December 18, 2021

Study information

Verified date October 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate whether researchers can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date December 18, 2021
Est. primary completion date December 18, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - DBS in one of the defined nuclei of interest during the period of the study - Be willing and able to give written and oral informed consent - Ability to complete all required study procedures including travelling to Mayo Clinic and staying overnight - All women of childbearing potential and women who have been amenorrheic for less than 1 year must practice effective contraception during the study. This includes a barrier method such as condom or diaphragm with spermicide; barrier intrauterine device (IUD) or abstinence. Exclusion Criteria: - Cognitive impairment (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This is including anyone who, in the opinion of the clinician taking consent is unlikely to retain sufficient mental capacity for the duration of their involvement in the study. - Patients with any other medical condition that would interfere with study conduct or make it unsafe for them to participate - Pregnancy test positive.

Study Design


Intervention

Device:
DBS Stimulation during sleep
Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participants to Complete Study Total number of participants to complete all scheduled study activities Through study completion, approximately 1 year
Secondary Total Sleep Time Length of sleep time reported in minutes Baseline, post-intervention (approximately 1 night)
Secondary Psychomotor Vigilance Test Measures reaction time (milliseconds) by asking subjects to press a button on an electronic device as soon as a light appears (every few seconds for 10 minutes). Baseline, post-intervention (approximately 1 night)
Secondary Karolinska Sleepiness Scale Measures subjective level of tiredness at a particular time during the day using a 9-point scoring scale of 1 = extremely alert, 3 = alert, 5 = neither alert nor sleepy, 7 = sleepy - but no difficulty remaining awake, and 9 = extremely sleepy - fighting sleep. Baseline, post-intervention (approximately 1 night)
Secondary Latency to Sleep Onset Time in minutes from beginning of study to the first stage of sleep Baseline, post-intervention (approximately 1 night)
Secondary Latency to Rapid Eye Movement (REM) Sleep Time in minutes from beginning of sleep to first REM sleep onset. Baseline, post-intervention (approximately 1 night)
Secondary Number of Sleep Cycles Total number of sleep cycles defined as switches of non-rapid eye movement (NREM) and rapid eye movement (REM) sleep. Baseline, post-intervention (approximately 1 night)
Secondary Number of Awakenings Per Night Total number of awakenings during night Baseline, post-intervention (approximately 1 night)
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