Essential Oils for Enhancing QOL in ASD

The purpose of the study is to evaluate the use of two fragrant oil formulations to enhance
quality of life by increasing relaxation and sleep quality in children with Autism Spectrum
Disorder (ASD). Essential oils (aromatic oils extracted from plant parts) are routinely used
by the public and are available on the market. Investigators are conducting this study
because it is unknown whether the essential oils formulations will be safe and effective for
helping children with ASD relax and sleep.

To participate in this study children must be between 3-9 years of age and have been
diagnosed with Autism Spectrum Disorder. Approximately 34 children and their families will be
enrolled in the study.

Participants will try two different fragrant oils in a double-blind randomized order. Each
child will receive each treatment for 3 months, with a 1-month "washout" period in between
during which no oil is used. Thus, participants could receive one of two possible treatment
courses:

The length of participation in the study is 7 months, with two 3-month treatment phases and
one 1-month washout period between the treatment phases. There will be one screening visit
(about 5 hours long, which can be split into 2 visits), two baseline visits (about 2 hours
each), two endpoint visits (2 hours each) and 5 other clinic visits (each 45-60 minutes).
Visits will take place at the OSU Nisonger Center and the OSU General Clinical Research
Center.

Inclusion Criteria:

- Outpatients between 3 and 9 years of age, inclusive;

- Diagnosis of Autism Spectrum Disorder (ASD) by DSM-V;

- Total score of > or = 1.5 PedsQL Inventory;

- Care provider who can reliably bring subject to clinic visits and provide trustworthy
ratings.

Exclusion Criteria:

- Bipolar disorder by Child & Adolescent Symptom Inventory (CASI, Gadow & Sprafkin,
1997) and clinical interview/history, or major depression accompanied by family
history of bipolar disorder;

- Children with allergies to essential oils;

- Children with seizure disorder/epilepsy;

- Significant physical illness (e.g., serious cardiovascular, liver or renal pathology);

- Medications specifically given for insomnia and exogenous melatonin, which have the
potential to confound study results, within the previous 2 weeks before baseline;

- Anticipated changes of doses of medication or other medical treatments or supplements;

- Weight less than 10 kg;

- Sleep Disordered Breathing (SDB) as defined by a total score of > or = 3 on the CSHQ
SDB subscale and parent report;

- Nut allergies;

- Allergy to vanilla;

- A substantial trial of essential oil use within the past 6 months (i.e., consistent
use for 6 weeks).