Essential Oils for Enhancing QOL in ASD
Completed · Phase 2
Conditions studied: Autism Spectrum Disorder, Quality of Life, Sleep, Anxiety
In brief
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 improving quality of life in children with Autism Spectrum Disorder (ASD) by helping them relax and sleep. Children invited to participate in this study must be between 3-9 years of age and have been diagnosed with Autism Spectrum Disorder. Twenty eight 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.
Key facts
- Study ID
- NCT02543203
- Run by
- Jill Hollway
- People needed
- 28
- Starts
- 2015-07-01
- Expected to finish
- 2018-03-16
- Last updated by the study team
- 2021-04-01
Who can join
Age: 3 and older, up to 9. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Outpatients between 3 and 9 years of age, inclusive;
- Diagnosis of Autism Spectrum Disorder (ASD) by DSM-V;
- Mean item score of > or = 1.5 PedsQL Inventory;
- Care provider who can reliably bring subject to clinic visits and provide trustworthy ratings.
You may not qualify if…
- 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).
Where it is running
- Ohio State University Nisonger Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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