Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia

There is evidence that when compared to normal controls, persons with insomnia exhibit
increased cognitive and physiological arousal and higher overall metabolic rate during
sleep, particularly at sleep onset. There is evidence that reducing this arousal may impact
sleep latency and nocturnal awake time. Although relaxation treatments have been integrated
into behavioral therapies, there are numerous barriers to their implementation in real world
settings. The present study is designed to examine the effect of a portable biofeedback
device designed to induce physiological relaxation as compared to an inactive sham control
device condition in reducing sleep onset latency in persons with primary insomnia over a 4
week period at three separate research sites.

Inclusion Criteria:

1. Between the ages of 18-55

2. Met DSM-IV-TR criteria for Primary Insomnia as measured by the:

- Structured Interview for Sleep Disorders.

- Insomnia Severity Index (>14).

3. Demonstrate Sleep Onset Latency of >=45 minutes on >= 3 nights per week greater than
or equal to 6 days over the 2 week period.

4. A mean SOL >= 30 minutes over the 2 week period between Screening and Baseline
visits.

5. Residential stability (1 year) and means to travel to appointments.

6. Willing to provide the name and contact information of a secondary contact person.

7. Off insomnia medications for at least one week prior to randomization and no more
than 2 days of use during the first week of baseline.

8. Ability to read in English.

9. Provision of informed consent.

10. Willing to comply with daily protocol.

11. Ability to obtain a reading on the device.

Exclusion Criteria:

1. Been in more than 2 studies in the past 2 years

2. Pregnant

3. Terminal, progressive, and or unstable medical illness.

4. Self-reported sleep disruptive medical disorder i. Chronic Pain, Fibromyalgia,
Pheochromocytoma, Hyperthyroidism, Congestive Heart Failure, Chronic Obstructive
Pulmonary Disease, Diabetes.

5. Current Axis I psychiatric disorder.(DSM-IV) i. Major Depressive Disorder,
Depression, Generalized Anxiety Disorder, Attention Deficit Disorder, Post Traumatic
Stress Disorder, Bipolar Disorder, Substance/Alcohol Use Disorders, Attention Deficit
Hyperactivity Disorder, Schizophrenia/Psychotic Disorders, Delirium, Dementia, and/or
Amnesic disorders, Panic Disorder w/ nocturnal panic attacks.

6. Chronic alcohol use not diagnosed in criterion 6. i. Subjects unwilling to limit
their alcohol intake to 2 standard drinks per day will be excluded.

7. Raynaud’s Disease

8. Regularly taking anti-anxiety medications, beta blockers or other heart medications
that regulate heartbeat, bronchodilators, respiratory stimulants, simulating
antidepressants, sedating antidepressants, thyroid supplements, anti-psychotics,
and/or steroids.

9. Regularly taking antidepressants (Prozac, Zoloft, Paxil) and NOT on a fixed dosage
for at least 1 month prior to entering the study.

10. Regularly taking medication (prescribed or over the counter) for sleep difficulties
(>3x week). Sleep medications include any substance for sleep not limited to but
including FDA approved sleep medications, analgesics, antihistamines, decongestants,
melatonin, L-trypotophan, and velarian.

11. Unwilling to abstain from PRN sleep aides (prescribed or over the counter).

12. Restless Leg Syndrome as assessed by structured interview.

13. Symptoms of Sleep Apnea (BMI>32 and Epworth Sleepiness Scale >10)

14. Own a negative air ionizer or have used one in the past to treat insomnia.

15. If subject recognizes device during the ability to obtain a pulse rate wave reading
on the device.

16. More than 5 cups (8oz) of caffeinated drinks per day and/or unwilling to limit
caffeine in-take to a maximum of 3 cups a day and not after 5pm during the
intervention.

17. Regular night-time shift work and rotating night-time shift work.

18. Idiopathic Insomnia.