Insomnia, Sleep
Conditions
Brief summary
Under entrained conditions, humans maintain a consolidated nocturnal sleep episode that coincides with environmental darkness and endogenous melatonin secretion. Various factors, such as artificial light, can compromise this temporal harmony, resulting in sleep disruption. Light is the strongest synchronizer of the circadian clock, with direct inputs via the retinohypothalamic tract to brain centers regulating sleep and circadian rhythms. Evening light exposure can suppress melatonin secretion and worsen sleep. This is critical, since most individuals routinely expose themselves to light before bedtime. The high sensitivity of the circadian system to blue wavelength light indicates that modern light sources such as light-emitting diodes (LED) may have particularly deleterious effects on sleep. It is possible to selectively filter out blue light while maintaining other visible spectra with blue-blocking (BB) lenses. Wearing BB lenses before bedtime may present a simple, affordable, and safe method to improve sleep. None have yet investigated the effects of BB lenses on subjective and objective sleep in insomnia patients, while simultaneously exploring the effects on melatonin secretion.
Detailed description
This study seeks to investigate the impact of BB lenses on melatonin and sleep in insomnia patients using a randomized, placebo-controlled crossover study, with the aim of developing a novel non-pharmacological approach for the treatment of insomnia. 15 individuals with insomnia will wear either BB or placebo (clear) lenses for 2 hours preceding bedtime while at home, for 1 week in a cross-over design. Sleep quality will be documented while at home, at also melatonin secretion while in the laboratory. It is predicted that compared to placebo, wearing BB lenses for 2 hours preceding bedtime will attenuate bright light associated melatonin suppression and improve sleep.
Interventions
DEVICEBlue blocking (BB) lenses
Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.
DEVICEClear lenses
Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Insomnia for at least 1 month based on Insomnia Symptoms Questionnaire
Exclusion criteria
* obstructive sleep apnea; narcolepsy; periodic leg movement disorder * currently shift worker * psychiatric or neurologic disorders * deep vein thrombosis * current cigarette smoker * currently taking beta-blockers * pregnant/breastfeeding * children less than 1 year old at home * excessive daily caffeine intake
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score | After 7 nights of BB lenses | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry | After 7 nights of BB lenses | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blue Blocking (BB)/Clear 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. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Blue Blocking (BB)/Clear |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 46.6 years STANDARD_DEVIATION 11.5 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black/African American | 6 Participants |
| Race/Ethnicity, Customized White | 6 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score
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)
Time frame: After 7 nights of BB lenses
Population: Participants who completed both phases
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Blocking (BB) | Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score | 72.64 units on a scale | Standard Deviation 28.14 |
Primary
Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score
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)
Time frame: After 7 nights of clear lenses
Population: Participants who complete both phases
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Blocking (BB) | Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score | 88.93 units on a scale | Standard Deviation 33.19 |
Secondary
Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry
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.
Time frame: After 7 nights of BB lenses
Population: Participants who completed both phases
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Blocking (BB) | 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
Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry
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.
Time frame: After 7 nights of clear lenses
Population: Participants who completed both phases
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Blocking (BB) | 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 |