The effects of bright light and physical activity at circadian rhythm disturbances in persons with MCI.

Withdrawn

• Conditions: slaapproblemen; Mild Cognitive Impairment (MCI); mild dementia; 10042258

• Registration Number: NL-OMON35034
• Lead Sponsor: Rijksuniversiteit Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

Mild Cognitive Impairment (MCI)
Having at least one sleeping problem
age 65 years or older
able to walk independently, use of walking aids (no wheelchair) are allowed

Exclusion Criteria

use of photosensitizing medication
presence of diseases of the eye other than due to normal aging
presence of diabetes Mellitus, epilepsy
history or presence of alcoholism, cerebral traumata, normal pressure hydrocephalus or neoplasm
presence of consciousness disturbances

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are objective outcomes related to sleep-wake and<br /><br>rest-activity rhythms of the participants assessed by Actigraphy.<br /><br>Outcomes related to the sleep-wake cycle are:<br /><br>1. total sleep time<br /><br>2. number and length of wake bouts during the night<br /><br>3. sleep efficiency (ratio of total sleep time and time spent in bed).<br /><br><br /><br>Outcomes according to rest-activity rhythm are:<br /><br>1. acrophase (time of peak activity)<br /><br>2. amplitude<br /><br>3. mesor (mean) of the 24 hour activity curve<br /><br>4. relative amplitude (RA; difference between 10 most active hours and 5<br /><br>least active hours)<br /><br>5. intradaily variability (IV; change in activity level from hour to hour)<br /><br>6. interdaily stability (IS; measures strength of activity rhythm to<br /><br>environmental zeitgebers, based on chi square periodogram).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measure is subjective quality of sleep, assessed by the<br /><br>14-item Groningen Sleep Quality Scale (GSQS)</p><br>