Trial Outcomes & Findings for Blue Wavelength Light-blocking Glasses in ADHD-Insomnia (NCT NCT01557595)

Last Updated: 2017-12-13

Results Overview

The PSQI is a validated self-rating instrument assessing aspects of sleep quality.Minimum score 0 (better); maximum score 21 (worse) \< or = 5 associated with good sleep quality; \> 5 associated with poor sleep quality. The PSQI is considered appropriate in identifying "new-onset" insomnia in the clinical setting.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

2 weeks post baseline

Results posted on

2017-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Adults With ADHD Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
Overall Study STARTED	22
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Blue Wavelength Light-blocking Glasses in ADHD-Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults With ADHD n=22 Participants Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
Age, Continuous	43.9 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants
Pittsburgh Sleep Quality Index	11.15 units on a scale STANDARD_DEVIATION 3.50 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks post baseline

Outcome measures

Outcome measures
Measure	Adults With ADHD n=14 Participants Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
Pittsburgh Sleep Quality Index (PSQI) at 2 Weeks After Baseline	4.54 units on a scale Standard Deviation 3.15

Adverse Events

Adults With ADHD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adults With ADHD n=22 participants at risk Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
General disorders pain on bridge of nose	4.5% 1/22
General disorders intermittent headache	4.5% 1/22

Additional Information

Dr. Rachel Fargason

UAB

Phone: 205-934-5151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place