Trial Outcomes & Findings for Blue Blockers at Night and Insomnia Symptoms (NCT NCT02698800)
NCT ID: NCT02698800
Last Updated: 2019-07-30
Results Overview
Pittsburgh Insomnia Rating Scale-65; measures the self-reported severity of insomnia over the past week. Higher scores indicate worsened severity. There are 65 items, each scored on a 4-point scale from low-high on symptom severity or frequency. There is a Total score, and 3 subscales: Distress score (how bothersome the sleep impairment is), Sleep Parameters score (sleep quality), and Quality of Life score. For the total score scoring is done by summing the scores from questions 1-65. Minimum Score=0 (good); Maximum Score=195 (bad) For the distress score, scoring is done by summing the scores from questions 1-46. Minimum Score=0 (not bothered); Maximum Score=138 (severely bothered) For the sleep parameters score, scoring is done by summing the scores from questions 47-56. Minimum Score=0 (good sleep); Maximum Score=30 (disrupted sleep) For the quality of life score, scoring is done by summing the scores from questions 57-65. Minimum Score=0 (excellent); Maximum Score=27 (poor)
COMPLETED
NA
15 participants
After 7 nights of BB lenses
2019-07-30
Participant Flow
Participant milestones
| Measure |
BB First (7 d), Then Clear (7 d), Separated by 4-wk Washout
Wearing of BB first for 7 days, followed by Clear lenses for 7 days, separated by 4-week washout period
Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.
Clear lenses: Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime
|
Clear First (7 ), Then BB (7 d), Separated by 4-wk Washout
Wearing Clear lenses first for 7 days, followed by BB lenses for 7 days, separated by a 4-week washout period
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blue Blockers at Night and Insomnia Symptoms
Baseline characteristics by cohort
| Measure |
Blue Blocking (BB)/Clear
n=14 Participants
Wearing of BB lenses.
Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.
Clear lenses: Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 7 nights of BB lensesPopulation: Participants who completed both phases
Pittsburgh Insomnia Rating Scale-65; measures the self-reported severity of insomnia over the past week. Higher scores indicate worsened severity. There are 65 items, each scored on a 4-point scale from low-high on symptom severity or frequency. There is a Total score, and 3 subscales: Distress score (how bothersome the sleep impairment is), Sleep Parameters score (sleep quality), and Quality of Life score. For the total score scoring is done by summing the scores from questions 1-65. Minimum Score=0 (good); Maximum Score=195 (bad) For the distress score, scoring is done by summing the scores from questions 1-46. Minimum Score=0 (not bothered); Maximum Score=138 (severely bothered) For the sleep parameters score, scoring is done by summing the scores from questions 47-56. Minimum Score=0 (good sleep); Maximum Score=30 (disrupted sleep) For the quality of life score, scoring is done by summing the scores from questions 57-65. Minimum Score=0 (excellent); Maximum Score=27 (poor)
Outcome measures
| Measure |
Blue Blocking (BB)
n=14 Participants
Wearing of BB lenses.
Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.
|
|---|---|
|
Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score
|
72.64 units on a scale
Standard Deviation 28.14
|
PRIMARY outcome
Timeframe: After 7 nights of clear lensesPopulation: Participants who complete both phases
Pittsburgh Insomnia Rating Scale-65; measures the self-reported severity of insomnia over the past week. Higher scores indicate worsened severity. There are 65 items, each scored on a 4-point scale from low-high on symptom severity or frequency. There is a Total score, and 3 subscales: Distress score (how bothersome the sleep impairment is), Sleep Parameters score (sleep quality), and Quality of Life score. For the total score scoring is done by summing the scores from questions 1-65. Minimum Score=0 (good); Maximum Score=195 (bad) For the distress score, scoring is done by summing the scores from questions 1-46. Minimum Score=0 (not bothered); Maximum Score=138 (severely bothered) For the sleep parameters score, scoring is done by summing the scores from questions 47-56. Minimum Score=0 (good sleep); Maximum Score=30 (disrupted sleep) For the quality of life score, scoring is done by summing the scores from questions 57-65. Minimum Score=0 (excellent); Maximum Score=27 (poor)
Outcome measures
| Measure |
Blue Blocking (BB)
n=14 Participants
Wearing of BB lenses.
Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.
|
|---|---|
|
Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score
|
88.93 units on a scale
Standard Deviation 33.19
|
SECONDARY outcome
Timeframe: After 7 nights of BB lensesPopulation: Participants who completed both phases
Wrist-worn accelerometry gives an estimate of time spent asleep, time spent in bed, and sleep efficiency can be calculated from this. Sleep efficiency is calculated as time spent asleep divided by total time in bed. Here, we considered the mean calculated sleep efficiency over each 7-day treatment period.
Outcome measures
| Measure |
Blue Blocking (BB)
n=14 Participants
Wearing of BB lenses.
Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.
|
|---|---|
|
Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry
|
78.35 % of total sleep time
Standard Deviation 9
|
SECONDARY outcome
Timeframe: After 7 nights of clear lensesPopulation: Participants who completed both phases
Wrist-worn accelerometry gives an estimate of time spent asleep, time spent in bed, and sleep efficiency can be calculated from this. Sleep efficiency is calculated as time spent asleep divided by total time in bed. Here, we considered the mean calculated sleep efficiency over each 7-day treatment period.
Outcome measures
| Measure |
Blue Blocking (BB)
n=14 Participants
Wearing of BB lenses.
Blue blocking (BB) lenses: Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.
|
|---|---|
|
Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry
|
77.01 % of total sleep time
Standard Deviation 8.67
|
Adverse Events
Blue Blocking (BB)
Clear
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ari Shechter, Principal Investigator
Columbia University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place