A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Sleep quality and quantity
Study Overview
Brief Summary
This is a case control study of the association between burning mouth syndrome and sleep dysfunction. Cases will comprise of patients diagnosed with burning mouth syndrome at the UCSF oral medicine clinic. Controls will include patients with leukoplakia, pigmented lesions, traumatic lesions, benign tumors, mucoceles, and pemphigoid matched on age (5 years) and gender to the cases. New patients as well as those presenting for follow-up visits will be eligible.
Each case and control subject will be administered the following 4 questionnaires by interview: (1) enrollment questionnaire (2) Sleep scale from the medical outcomes study (MOS), (3) current sleep status scale and (4) a numerical rating scale for measurement of oral symptoms.
Cases (BMS patients) will be followed in the clinic or by telephone contact once per month for the following 6 months and questionnaires 1 (question 6 only), 2, 3 and 4 will be administered by interview.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cases will comprise of patients diagnosed with burning mouth syndrome at the UCSF oral medicine clinic.
- •Controls will include patients with leukoplakia, pigmented lesions, traumatic lesions, aphthous ulcers, reticular oral lichen planus, benign tumors, mucoceles, and pemphigoid matched on age (5 years) and gender to the cases.
- •New patients as well as those presenting for follow-up visits will be eligible.
Exclusion Criteria
- •Age below 18 years
- •Pregnancy
- •Systemic corticosteroid therapy within the previous 2 weeks.
Outcomes
Primary Outcomes
Sleep quality and quantity
Secondary Outcomes
No secondary outcomes reported