The purpose of this study is to evaluate sleep in participants with Major Depressive Disorder with moderate to severe insomnia symptoms (MDDIS) or MDD with no or mild insomnia symptoms (non-MDDIS), using an at-home sleep Electroencephalogram (EEG; a device that records brain activity during sleep). The study also aims to examine the association between objective sleep EEG features (measured using devices) and subjective sleep measures (self-reported experiences, such as how a person feels about their sleep) in participants with MDDIS or non-MDDIS.

A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major Depressive Disorder (MDD)

Depressive Disorder, Major

Major Depressive Disorder With Anxious Distress

Depressive Disorder

Depression

Mood disorders

Brain and Nervous System Conditions

A Study to Evaluate Sleep Electroencephalogram (EEG) Features in Participants With Major Depressive Disorder (MDD)

Objective sleep EEG features in MDD participants will be assessed using dreem 3S headband. It will be used in this study to capture macro and micro sleep architecture including sleep initiation (latent to persistent sleep, sleep onset latency), sleep maintenance (rapid eye movement [REM] latency, total sleep time, REM percentage, and duration) and arousal features (stage shift index, number of awakenings). It also uses a 3D accelerometer to measure movements, head position, and respiratory rate/trace during sleep.

Subjective sleep EEG features in MDD participants will be assessed using CSD. Participants will be asked to provide answers to questions to determine their subjective experience of nighttime sleep, daytime napping/dozing, feeling refreshed upon awakening, and the usage of over-the-counter and prescription sleep aids and the Dreem 3S headband by recording their answers in a daily sleep diary (CSD). CSD will be used in this study to capture the parameters including self-reported sleep onset latency, subjective total sleep time, subjective wake after sleep onset, subjective number of nighttime awakenings, subjective quality of sleep, subjective refreshed feeling on waking, self-reported number of naps, self-reported nap time, self-reported sleep aids, self-reported sleep impact while utilizing Dreem 3S headband.

Subjective sleep EEG features in MDD participants will be assessed using SIGH-D used to implement HRSD17 scale. The structured interview guide SIGH-D will be used to implement the HRSD17. HRSD17 scale contains 17 items pertaining to symptoms of depression experienced over the past week. The questions cover core symptoms of depression as well as appetite and sleep (3 items). Items are scored on a Likert scale of 0-4 or 0-2 depending on the item with a possible range of 0-54.

Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-8a. PROMIS-SD-8a uses all items on the 8a form. The PROMIS-SD instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep).

Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-4a. PROMIS-SD-4a uses 4 of the 8 items on the 8a form. The PROMIS-SD instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep).

Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-10a. PROMIS-SD-10a uses all items on both the 8a and 2a forms. The PROMIS-SD instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep).

Subjective sleep EEG features in MDD participants will be assessed using patient and clinician version of ISI. The clinician version of the ISI will be completed by an independent rater. The ISI is a 7-item questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. A 5-point Likert scale (0-4) is used to rate each item, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0 7); sub threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

The MDDIS cohort includes participants with moderate to severe insomnia symptom severity as measured by clinical outcome assessments during the screening phase.

The Non-MDDIS cohort includes participants with no or mild insomnia symptoms as measured by clinical outcome assessments during the screening phase.

The purpose of this study is to evaluate sleep in participants with Major Depressive
Disorder with moderate to severe insomnia symptoms (MDDIS) or MDD with no or mild
insomnia symptoms (non-MDDIS), using an at-home sleep Electroencephalogram (EEG; a device
that records brain activity during sleep). The study also aims to examine the association
between objective sleep EEG features (measured using devices) and subjective sleep
measures (self-reported experiences, such as how a person feels about their sleep) in
participants with MDDIS or non-MDDIS.

Objective sleep EEG features in MDD participants will be assessed using dreem 3S
headband. It will be used in this study to capture macro and micro sleep architecture
including sleep initiation (latent to persistent sleep, sleep onset latency), sleep
maintenance (rapid eye movement [REM] latency, total sleep time, REM percentage, and
duration) and arousal features (stage shift index, number of awakenings). It also uses a
3D accelerometer to measure movements, head position, and respiratory rate/trace during
sleep.

Subjective sleep EEG features in MDD participants will be assessed using CSD.
Participants will be asked to provide answers to questions to determine their subjective
experience of nighttime sleep, daytime napping/dozing, feeling refreshed upon awakening,
and the usage of over-the-counter and prescription sleep aids and the Dreem 3S headband
by recording their answers in a daily sleep diary (CSD). CSD will be used in this study
to capture the parameters including self-reported sleep onset latency, subjective total
sleep time, subjective wake after sleep onset, subjective number of nighttime awakenings,
subjective quality of sleep, subjective refreshed feeling on waking, self-reported number
of naps, self-reported nap time, self-reported sleep aids, self-reported sleep impact
while utilizing Dreem 3S headband.

Subjective sleep EEG features in MDD participants will be assessed using SIGH-D used to
implement HRSD17 scale. The structured interview guide SIGH-D will be used to implement
the HRSD17. HRSD17 scale contains 17 items pertaining to symptoms of depression
experienced over the past week. The questions cover core symptoms of depression as well
as appetite and sleep (3 items). Items are scored on a Likert scale of 0-4 or 0-2
depending on the item with a possible range of 0-54.

Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-8a.
PROMIS-SD-8a uses all items on the 8a form. The PROMIS-SD instrument assesses
self-reported perceptions of sleep quality, sleep depth, and restoration associated with
sleep. This includes perceived difficulties and concerns with getting to sleep or staying
asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep
Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide
subjective estimates of sleep quantities (total amount of sleep, time to fall asleep,
amount of wakefulness during sleep).

Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-4a.
PROMIS-SD-4a uses 4 of the 8 items on the 8a form. The PROMIS-SD instrument assesses
self-reported perceptions of sleep quality, sleep depth, and restoration associated with
sleep. This includes perceived difficulties and concerns with getting to sleep or staying
asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep
Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide
subjective estimates of sleep quantities (total amount of sleep, time to fall asleep,
amount of wakefulness during sleep).

Subjective sleep EEG features in MDD participants will be assessed using PROMIS-SD-10a.
PROMIS-SD-10a uses all items on both the 8a and 2a forms. The PROMIS-SD instrument
assesses self-reported perceptions of sleep quality, sleep depth, and restoration
associated with sleep. This includes perceived difficulties and concerns with getting to
sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with
sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does
it provide subjective estimates of sleep quantities (total amount of sleep, time to fall
asleep, amount of wakefulness during sleep).

Subjective sleep EEG features in MDD participants will be assessed using patient and
clinician version of ISI. The clinician version of the ISI will be completed by an
independent rater. The ISI is a 7-item questionnaire assessing the nature, severity, and
impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep
maintenance, early morning awakening problems; sleep dissatisfaction; interference of
sleep problem with daytime functioning; noticeability of sleep problems by others; and
distress caused by the sleep difficulties. A 5-point Likert scale (0-4) is used to rate
each item, yielding a total score ranging from 0 to 28. The total score is interpreted as
follows: absence of insomnia (0 7); sub threshold insomnia (8-14); moderate insomnia
(15-21); and severe insomnia (22-28).

The MDDIS cohort includes participants with moderate to severe insomnia symptom severity
as measured by clinical outcome assessments during the screening phase.

The Non-MDDIS cohort includes participants with no or mild insomnia symptoms as measured
by clinical outcome assessments during the screening phase.

A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major Depressive Disorder (MDD)

Trials at a glance

Trials at a glance

A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major Depressive Disorder (MDD)

Outcome measures

Primary outcome measures