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

Status unconfirmed

Conditions studied: Headache Disorder, Sleep Disorder, Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT00520156

Run by

Walter Reed Army Medical Center

People needed

600

Starts

2007-08-01

Expected to finish

2008-08-01

Last updated by the study team

2007-08-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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