A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome

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.

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Key information

Conditions

Burning Mouth Syndrome Chronic Pain Facial Pain Glossalgia Mouth Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Stomatognathic Diseases Tongue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Sleep quality and quantity

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Mar 17, 2009
Registry last updated: Mar 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed