Acupuncture for the Treatment of Insomnia

Insomnia is a common problem that is disabling and that frequently persists despite available
medical and behavioral approaches. It is associated significant psychiatric and medical
comorbidities and high medical and societal costs. Benzodiazepine receptor agonists (BzRA's)
and cognitive behavioral therapies are common treatments, but despite these, insomnia remains
a pervasive problem. Complementary and alternative medicine (CAM) treatments are being used
widely for the treatment of insomnia, but many of these modalities have sparse research
support. There are numerous reports in the Traditional Chinese Medicine (TCM)literature of
dramatic benefits of acupuncture for the treatment of insomnia, but carefully designed
studies are limited. Insomnia has been associated with hyperarousal and acupuncture has
documented effects on autonomics with a shift towards parasympathetic predominance. In
consultation with experts in acupuncture and TCM, we developed a protocol for the treatment
of insomnia and have used it clinically with good success.

We will be conducting a 3-year exploratory pilot randomized-controlled blinded trial (RCT) of
this protocol on 56 adults with insomnia disorder, utilizing a control condition involving
placement of placebo needles. We seek to determine the effect size of this acupuncture
intervention in comparison to the control condition in preparation for a more definitive
study, with the future primary aim to determine if acupuncture is effective and well
tolerated in the treatment of insomnia. Measures will include self-report and objective
measures of sleep quality and duration including polysomnography (PSG). Secondary-exploratory
aims will be to determine the impact of this acupuncture protocol on daytime symptoms of
insomnia such as fatigue, anxiety, and depression as well as to explore the impact of
acupuncture on self-report and objective measures of hyperarousal.

Inclusion Criteria:

1. Ages 18-60;

2. Ability to speak, read, and write English;

3. Insomnia disorder, as defined by RDC, of 3 months or greater duration.

Exclusion Criteria:

1. Presence of serious psychiatric Axis I DSM-IV disorders such as bipolar or psychotic
disorders—as individuals with conditions may respond differently than insomnia
disorder to the acupuncture intervention, potentially confounding the results;

2. Active suicidal ideation or active psychosis, as this may present a concern regarding
safety for a subject's participation in this study;

3. Presence of depressive or anxiety disorders of moderate or greater severity based on
either HAM-D scores or HAM-A scores of 14 or greater;

4. Presence of unstable medical conditions commonly associated with significant sleep
disturbance, e.g. uncompensated congestive heart failure, as this would not be
expected to respond to the acupuncture intervention;

5. Presence of other sleep disorder, such as periodic limb movement disorder or sleep
apnea, as these conditions would require other medical treatment—this will be based on
known history of sleep disorder or findings on screening PSG of apnea-hypopnea index
of > 10 or periodic limb movement index of >10;

6. Alcohol use > 14 beverages/week, as this may impact on response to the intervention
and assessment measures;

7. Ongoing use of any recreational drugs;

8. Ongoing use of benzodiazepines, prescription hypnotic medication, over-the-counter
hypnotic medication, or nutritional supplements with purported hypnotic effects;

9. Ongoing use of other psychotropic medication, such as psychostimulants, or
antipsychotics;

10. Caffeine use > the equivalent of 5 cups of coffee/day;

11. Pregnancy, as the safe use of acupuncture in pregnancy has not been established;

12. Active malignancy, autoimmune condition, or treatment with immunosuppressive drugs;

13. Presence of coagulopathy or use of anticoagulant medication;

14. Active involvement in any psychotherapy or other treatment specifically directed
towards insomnia;

15. Prior experience with acupuncture treatment in the last 6 months or prior
participation in an acupuncture research study.