Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia

Insomnia is a common and distressing medical condition that affects nearly 20% of U.S.
adults, and persistent (or chronic) insomnia affects nearly 10-15% of U.S. adults. In a
community-based prospective observational study, preliminary data suggests that insomnia is
associated with hospitalizations due to cardiovascular, cancer, or any cause over a 4-year
period. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered the gold-standard in
the treatment of insomnia. There are 5 components of CBT-I, sleep restriction therapy,
stimulus control instructions, relaxation training, cognitive therapy, and sleep hygiene
education. In an ongoing study of CBT-I in recently hospitalized patients, the investigators
found a high prevalence of insomnia (80%) and were able to administer CBT-I in the
participants' home via iPADs with wireless connectivity and secure video-chat software.
Recently hospitalized patients who are recuperating in their homes would find it difficult to
return for weekly visits with a clinical psychologist and therefore could benefit from the
convenience of CBT-I treatment administered in the patient's homes via the wireless iPAD and
video chat software. The AASM SleepTM platform could conceivably allow performance of CBT-I
without the added expense of an iPAD. The investigators are proposing to perform a
non-inferiority trial of telemedicine CBT-I (AASM SleepTM) versus conventional office-based
CBT-I that is performed in patients with insomnia who have been recently discharged from the
hospital. The investigators will measure the following outcomes: insomnia severity index
(primary outcome) and patient satisfaction. In the future, the investigators' program of
research aims to improve understanding of whether insomnia represents a modifiable risk
factor for re-hospitalizations in patients who are high utilizers of healthcare services.

Specific Aim 1: To perform comparative effectiveness research of CBT-I administered by
telemedicine versus conventional office-based CBT-I on insomnia severity in recently
hospitalized patients.

Hypothesis #1: In recently hospitalized patients with insomnia, after six weeks of CBT-I
treatment, the mean improvement in ISI score among patients treated by telemedicine CBT-I
(AASM SleepTM) would be no more than 3-points less than that in patients treated by
conventional office-based CBT-I.

Specific Aim 2: To perform comparative effectiveness research of CBT-I administered by
telemedicine versus conventional office-based CBT-I on patient satisfaction.

Hypothesis #2: In recently hospitalized patients with insomnia, after six weeks of CBT-I
treatment, the mean improvement in patient satisfaction score (Consumer Assessment of Health
Plans Survey [CAHPS v4.0] item) among patients treated by telemedicine CBT-I (AASM SleepTM)
would be no more than 1-point less than that in patients treated by conventional office-based
CBT-I.

Inclusion Criteria:

- Medically ill patients with recent hospitalization who are being discharged to home.

- ISI score of > 10 (chronic insomnia)

- Age > 18 years

- Ability to provide informed consent

- Willingness to undergo sleep study

Exclusion Criteria:

- Presence of untreated sleep disorder that requires treatment independent of insomnia
(Narcolepsy, restless leg syndrome, or REM sleep behavior disorder)

- Patients with severe debilitating neurological disease (end-stage Alzheimer's, large
stroke, or other debilitating neurological disease) or any other condition that
renders patients incapable of providing informed consent

- History of Bipolar disease; current or past (< 6 months) history of suicidality or
suicidal ideation

- Active substance abuse or alcoholism

- Pregnancy or lactation