Headache DisorderNCT00520156
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
An observational study of Headache Disorder and Sleep Disorder, run by Walter Reed Army Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache Disorder, Sleep Disorder, Obstructive Sleep Apnea
- What is being tested?
- Continuous positive airway pressure (CPAP)
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age below 18 or over 80
- Inability to understand and sign an informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
Timothy M. Quast, MD, 202-782-5721, tnquast@bethesda.med.navy.mil
About this study
Official title: Analysis of the Prevalence and Characteristics of Co-Morbid Sleep and Headache Disorders in Patients Being Evaluated at the WRAMC Sleep Disorders Laboratory, and the Efficacy of CPAP Treatment on Headache Burden in Obstructive Sleep Apnea Patients With a Co-Morbid Headache Disorder
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.
Read more
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.
Read the detailed description
There is a well-documented but poorly understood relationship between headache disorders (e.g. migraine, cluster headaches, awakening headaches, etc.) and sleep disorders. The exact prevalence of patients with concomitant headache disorder and sleep disorder is not even known. Hypotheses surrounding the relationship include low overnight oxygen saturation and/or hypercarbia in the case of obstructive sleep apnea (OSA) with awakening headache, primary headache disorder as a contributor to secondary sleep disorder, atypical lengths or percentages of time in various sleep stages resulting in disordered sleep patterns and subsequent headache, bruxism causing tension type headaches, among others. Our review of the literature shows there has not yet been a prospective trial evaluating headache disorders and concomitant sleep disorders with attempts to find vagaries or abnormalities in terms of sleep parameters as a way to explain headache disorder.
Additionally, although there have been few retrospective reviews of small numbers of patients examining an intervention (in this case, the addition of continuous positive airway pressure - CPAP) as a means to correct a sleep disorder with a subsequent evaluation of the patient's pre-existing headache disorders, there has yet to be a prospective trial evaluating same. Our team identified at least one retrospective study that would suggest that treating OSA with standard of care CPAP improved pre-existing symptoms of headache.
Our study proposes to - after obtaining consent - survey patients with suspected sleep disorders who have been scheduled for a sleep study to evaluate the overall prevalence of headache disorder among this particular population. We would then evaluate various standard sleep study parameters such as lowest oxygen saturation, time in various sleep stages, sleep latency, total sleep time, respiratory disturbance index, presence of bruxism, and so on, to see whether there is a correlation between certain of these parameters and a particular headache disorder. We also would survey those patients diagnosed with OSA following institution of CPAP to see whether there was a decrement or cessation in headache frequency or intensity.
Being that a significant proportion of our patients are returning war veterans with possible traumatic brain injuries or post-traumatic stress disorder, we would also query patients regarding the presence of these disorders. These data would be taken into account as a sub-analysis of the overall data set.
The study will be of 12 months duration. Over 2000 sleep studies are performed at our institution in 12 months. We anticipate an enrollment of between 400 to 800 subjects.
- Conditions
- Headache Disorder, Sleep Disorder, Obstructive Sleep Apnea
- Being tested
- Continuous positive airway pressure (CPAP)
- Medical subject headings
- Headache Disorders, Sleep Wake Disorders, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startAug 2007
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Timothy M. Quast, MD, Principal investigator, Pulmonary, Critical Care, and Sleep Medicine; National Capital Consortium, Washington, DC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520156
- Sponsor's protocol ID
- 07-17021
- Status last verified
- Aug 2007
- First submitted
- 21 Aug 2007
- Last updated
- 23 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Prevalence and Characteristics of Co-Morbid Sleep and Headache Disorders in Patients Being Evaluated at the WRAMC Sleep Disorders Laboratory, and the Efficacy of CPAP Treatment on Headache Burden in Obstructive Sleep Apnea Patients With a Co-Morbid Headache Disorder
- ClinicalTrials.gov ID
- NCT00520156
- Acronym / sponsor ID
- 07-17021
- Conditions
- Headache Disorder, Sleep Disorder, Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Aug 2007
- Study completion
- Aug 2008 (estimated)
- First posted
- 23 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is a well-documented but poorly understood relationship between headache disorders (e.g. migraine, cluster headaches, awakening headaches, etc.) and sleep disorders. The exact prevalence of patients with concomitant headache disorder and sleep disorder is not even known. Hypotheses surrounding the relationship include low overnight oxygen saturation and/or hypercarbia in the case of obstructive sleep apnea (OSA) with awakening headache, primary headache disorder as a contributor to secondary sleep disorder, atypical lengths or percentages of time in various sleep stages resulting in disordered sleep patterns and subsequent headache, bruxism causing tension type headaches, among others. Our review of the literature shows there has not yet been a prospective trial evaluating headache disorders and concomitant sleep disorders with attempts to find vagaries or abnormalities in terms of sleep parameters as a way to explain headache disorder.
Additionally, although there have been few retrospective reviews of small numbers of patients examining an intervention (in this case, the addition of continuous positive airway pressure - CPAP) as a means to correct a sleep disorder with a subsequent evaluation of the patient's pre-existing headache disorders, there has yet to be a prospective trial evaluating same. Our team identified at least one retrospective study that would suggest that treating OSA with standard of care CPAP improved pre-existing symptoms of headache.
Our study proposes to - after obtaining consent - survey patients with suspected sleep disorders who have been scheduled for a sleep study to evaluate the overall prevalence of headache disorder among this particular population. We would then evaluate various standard sleep study parameters such as lowest oxygen saturation, time in various sleep stages, sleep latency, total sleep time, respiratory disturbance index, presence of bruxism, and so on, to see whether there is a correlation between certain of these parameters and a particular headache disorder. We also would survey those patients diagnosed with OSA following institution of CPAP to see whether there was a decrement or cessation in headache frequency or intensity.
Being that a significant proportion of our patients are returning war veterans with possible traumatic brain injuries or post-traumatic stress disorder, we would also query patients regarding the presence of these disorders. These data would be taken into account as a sub-analysis of the overall data set.
The study will be of 12 months duration. Over 2000 sleep studies are performed at our institution in 12 months. We anticipate an enrollment of between 400 to 800 subjects.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Age below 18 or over 80
- Inability to understand and sign an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressure (CPAP)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. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy M. Quast, MD principal investigator
Pulmonary, Critical Care, and Sleep Medicine; National Capital Consortium, Washington, DC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache Disorder and Sleep Disorder, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothy M. Quast, MD ((301)295-4191, timothy.quast@amedd.army.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2007; AzTrials last refreshed its copy on 8 Nov 2026.