Light to Maximize Vision, Minimize Insomnia

Postural Balance Clinical Trial

Official title:

Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712243
• Other study ID #: 1I21RX000773-01A2
• Status: Completed
• Phase: N/A
• First received: October 19, 2012
• Last updated: November 1, 2016
• Start date: December 2013
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Department of Veterans Affairs
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether specific wavelengths of light at night can be used to improve mobile balance while simultaneously not increasing alertness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Aged 55-85

• At least 20/200 corrected visual acuity

• Greater than 20° visual field with no lower visual field loss

• Stable health

• Male or female

• Normal color vision

• Normal hearing

Exclusion Criteria:

• Extreme chronotype

• Sleep disorders

• Dementia

• Smoker

• Depression

• Alcohol abuse

• Use of illegal drugs

• Use of sleep/wake altering drugs on an acute or as needed basis (including nutraceuticals, antihistamines)

• Use of light sensitizing drugs

• Self-reported history of nocturia (>3 times per night)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Postural Balance

Intervention

Other:
• Light

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobile balance	Mobile balance as determined using a GaitRite walkway	15 minutes	No
Primary	Alertness	Alertness as determined by electroencephalographic power density	15 minutes	No