Jet Lag Type Insomnia
Conditions
Brief summary
The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.
Interventions
DRUGTasimelteon
Oral capsule
DRUGPlacebo
Oral capsule
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability and acceptance to provide written consent, fluent in English; * Healthy subjects with no medical, psychiatric or current sleep disorders; * Men or women between 18-75 years; * Body Mass Index of ≥ 18 and ≤ 30 kg/m2.
Exclusion criteria
* Major surgery, trauma, illness or immobile for 3 or more days within the past month; * Pregnancy or recent pregnancy (within 6 weeks); * A positive test for drugs of abuse at the screening or evaluation visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time in the First Two Thirds of the Night | 1 Day | Total sleep time during the first 2/3 of the night following an 8-hour phase advance bedtime, as measured by PSG. This is representative of trans meridian travel across 8 time zones. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time | 1 Day | Total Sleep Time as measured by PSG. |
| Latency to Persistent Sleep | 1 Day | Length of time elapsed between lights out and onset of persistent sleep as measure by PSG. |
| Wake After Sleep Onset | 1 Day | The amount of wake time during the sleep period after sleep onset (as measured by polysomnography). |
| Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score) | 1 Day | A 9-point scale that measures subjective levels of fatigue by asking how sleepy subjects feel at that moment: 1 = extremely awake to 9 =extremely sleepy/fighting to stay awake. |
| Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score) | 1 Day | The VAS was a self-rated scale to assess sleepiness. Participants marked along a 100 mm line to represent their current state of sleepiness, 0 being very sleepy and 100 being very alert. The VAS was administered four times following the dose administration after awakening. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tasimelteon Tasimelteon: Oral capsule | 159 |
| Placebo Placebo: Oral capsule | 159 |
| Total | 318 |
Baseline characteristics
| Characteristic | Tasimelteon | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 35.8 years STANDARD_DEVIATION 11.2 | 35.9 years STANDARD_DEVIATION 12.63 | 35.8 years STANDARD_DEVIATION 11.92 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 15 participants | 13 participants | 28 participants |
| Race/Ethnicity, Customized Black or African American | 44 participants | 47 participants | 91 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 5 participants | 2 participants | 7 participants |
| Race/Ethnicity, Customized White | 94 participants | 97 participants | 191 participants |
| Sex: Female, Male Female | 86 Participants | 81 Participants | 167 Participants |
| Sex: Female, Male Male | 73 Participants | 78 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 160 | 0 / 160 |
| other Total, other adverse events | 8 / 160 | 4 / 160 |
| serious Total, serious adverse events | 1 / 160 | 0 / 160 |
Outcome results
Primary
Total Sleep Time in the First Two Thirds of the Night
Total sleep time during the first 2/3 of the night following an 8-hour phase advance bedtime, as measured by PSG. This is representative of trans meridian travel across 8 time zones.
Time frame: 1 Day
Population: Intent-to-Treat Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Sleep Time in the First Two Thirds of the Night | 156.1 Minutes | Standard Deviation 80.67 |
| Tasimelteon | Total Sleep Time in the First Two Thirds of the Night | 216.4 Minutes | Standard Deviation 69.69 |
p-value: <0.000195% CI: [44, 76.7]ANOVA
Secondary
Latency to Persistent Sleep
Length of time elapsed between lights out and onset of persistent sleep as measure by PSG.
Time frame: 1 Day
Population: Intent-to-Treat Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Latency to Persistent Sleep | 36.8 Minutes | Standard Deviation 63.56 |
| Tasimelteon | Latency to Persistent Sleep | 21.8 Minutes | Standard Deviation 33.69 |
p-value: <0.000195% CI: [-26.2, -4]ANOVA
Secondary
Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)
A 9-point scale that measures subjective levels of fatigue by asking how sleepy subjects feel at that moment: 1 = extremely awake to 9 =extremely sleepy/fighting to stay awake.
Time frame: 1 Day
Population: Intent-to-Treat Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score) | 4.5 Night 1 average score | Standard Deviation 1.86 |
| Tasimelteon | Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score) | 4.0 Night 1 average score | Standard Deviation 1.77 |
p-value: 0.008395% CI: [-0.9, -0.1]ANOVA
Secondary
Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score)
The VAS was a self-rated scale to assess sleepiness. Participants marked along a 100 mm line to represent their current state of sleepiness, 0 being very sleepy and 100 being very alert. The VAS was administered four times following the dose administration after awakening.
Time frame: 1 Day
Population: Intent-to-Treat Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score) | 54.2 Night 1 Average Score in millimeters | Standard Deviation 23.46 |
| Tasimelteon | Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score) | 60.8 Night 1 Average Score in millimeters | Standard Deviation 22.24 |
p-value: 0.009995% CI: [1.6, 11.6]ANOVA
Secondary
Total Sleep Time
Total Sleep Time as measured by PSG.
Time frame: 1 Day
Population: Intent-to-Treat Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Sleep Time | 230.3 Minutes | Standard Deviation 97.39 |
| Tasimelteon | Total Sleep Time | 315.8 Minutes | Standard Deviation 95.51 |
p-value: <0.000195% CI: [64.3, 106.6]ANOVA
Secondary
Wake After Sleep Onset
The amount of wake time during the sleep period after sleep onset (as measured by polysomnography).
Time frame: 1 Day
Population: Intent-to-Treat Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Wake After Sleep Onset | 219.1 Minutes | Standard Deviation 96.9 |
| Tasimelteon | Wake After Sleep Onset | 144.6 Minutes | Standard Deviation 86.73 |
p-value: <0.000195% CI: [-94.8, -54.3]ANOVA