Analysis of the Prevalence and Characteristics of Concomitant Sleep and Headache Disorders, and the Efficacy of CPAP Treatment for Headache Among Those Patients Diagnosed With Obstructive Sleep Apnea

NCT00520156 | Unknown DMC

• 1 other identifier: 07-17021
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

There is a well-documented but poorly understood relationship between headache disorders (e.g. migraine, cluster headaches, awakening headaches, etc.) and sleep disorders. One hypothesis includes an underlying disorder known as obstructive sleep apnea (OSA) with low overnight oxygen saturations and possibly elevated carbon dioxide levels which result in awakening headache. Bruxism, or grinding of the teeth, has also been anecdotally associated with headache. The converse of these arguments is that the patient may have a primary headache disorder, for example migraine, leading to disordered sleep patterns or insomnia. The true relationship between the two, as alluded above, is unknown. The actual prevalence of the two disorders occurring simultaneously is not known. There have been several small, retrospective studies which have attempted to evaluate this relationship. One of these studies evaluated those patients diagnosed with OSA who were given the standard of care therapy - continuous positive airway pressure (CPAP) - and found that headaches among these patients were improved after using CPAP. Again, this was a small, retrospective study. We propose a study whereby patients who are referred for polysomnography (PSG, or "sleep study") are consented, then surveyed on the presence or absence of headache. A brief questionnaire is followed up with a more detailed questionnaire to characterize whether this headache that the patient has is truly a headache disorder. Following the survey and PSG, the patient's sleep study parameters are evaluated to see whether there are certain correlations between what has been recorded and the particular headache disorder present. Lastly, if the patient was diagnosed with OSA and fitted with a CPAP device, the patient will be queried several weeks later to evaluate whether there was improvement or cessation of the headache disorder.

Conditions

Headache Disorder; Sleep Disorder; Obstructive Sleep Apnea

Interventions

Continuous positive airway pressure (CPAP) DEVICE

Patients diagnosed with obstructive sleep apnea (OSA) will be offered standard of care treatment of CPAP (patients given oral appliances for OSA are excluded from our study). Note: our study is a survey-based and observational study following patients who are being evaluated for sleep disorders. Those patients diagnosed with OSA would be offered CPAP or possibly an oral appliance regardless of whether they are entered into our study or not.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have been screened at the Walter Reed Army Medical Center (WRMAC) sleep clinic with chief complaint of sleep disorder and have been scheduled for an overnight PSG at WRAMC. Sleep symptoms may include such difficulties as initiating sleep, maintaining sleep, disturbed sleep, not feeling refreshed in the morning, sleepiness during the day, and snoring
• Ages 18-80
• Satisfactory completion of sleep and headache inventory
• Satisfactory completion of overnight polysomnogram
• May have used sleeping preparations
• May have used anti-migraine medication
• May have other medical conditions and be on other medications

You may not qualify if:

• Age below 18 or over 80
• Inability to understand and sign an informed consent

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Headache Disorders; Sleep Wake Disorders; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Timothy M. Quast, MD

  Pulmonary, Critical Care, and Sleep Medicine; National Capital Consortium, Washington, DC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy M. Quast, MD

CONTACT

(301)295-4191; timothy.quast@amedd.army.mil

Kimbra Kenney, MD

CONTACT

301-295-0198; kkenney@usuhs.mil

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED

Study Record Dates

• First Submitted: August 21, 2007
• First Posted: August 23, 2007
• Study Start: August 1, 2007
• Study Completion: August 1, 2008
• Last Updated: August 23, 2007

Record last verified: 2007-08

Locations

US (1)