Looking for ways to diversify your sleep lab? Would you like to help develop new treatments and attract more patients? To be "in the know" about new therapies and current care recommendations? To consult with experts in the field of sleep medicine? What if there was a way to contribute to the advancement of sleep medicine? There is a way. It's called research.

In its simplest form, research is performed to answer a question. The findings from the research can then aid in the prevention, detection, diagnosis, control, and/or treatment of illnesses. Two of the hottest areas in sleep research are also the most diagnosed sleep disorders: sleep apnea and insomnia. A quick search at clinicaltrials.gov finds 481 sleep studies currently under way, 114 sleep apnea studies and 96 studies related to insomnia. One might assume that since there are many studies being conducted, funding is available to conduct them. In order to be able to obtain funding and conduct relevant research, you first must be prepared.

Purpose of Research

The first step in conducting research is to determine the purpose of conducting a study. Sleep labs that want to conduct research should develop an objective that is possible to achieve and that is not already common knowledge. The potential researcher should devise a plan for how they are going to conduct the research and begin putting their study into perspective by structuring it on the existing knowledge base of prior research.

Training

Once the research goal and plan are defined, the staff and principal investigator (PI) will have to be sure they are properly trained to engage in the research process. Sleep lab support staff can receive training from such organizations as the Association of Clinical Research Professionals or the Society of Clinical Research Associates. Sleep techs can be trained in several ways to do clinical studies. There are college programs, independent schools, and on-the-job training. Often, training can be done by the PI. It is important to note that any training should be documented and that this documentation should be able to be readily produced for review by the sponsor or an audit.

Equally important to staff training is that the PI have the necessary skills and leadership to head the study. Training for the PI generally comes from personal experience. Susan Redline, MD, a director for the Sleep Research Society, states, "[Principal investigators] work for it—gain skills, design research studies, are part of a fellowship or other training programs." If a fellowship or training program is not an option, then Tim Richardson, director of site management for Trinity Clinical Trials, recommends, "The best way to get training is to have the investigator act as a subinvestigator on another trial. This will build up his CV as well as get a feel for how clinical trials are performed."

Equipment

During the past couple of years, there has been a surge in stand-alone sleep labs. Although the number of labs is increasing, new sleep centers, whether in a hospital setting or stand-alone, may not have the equipment to perform vital signs, ECGs, lab work (blood draws, urine screens, blood processing), or neurological testing.

Arrangements may have to be made for these tasks to be done. These arrangements may include purchasing an ECG machine, blood pressure kits, and a centrifuge to process blood work. Storing items may require double-locked rooms for medication, a refrigerator, or a freezer. In some cases, more space may have to be obtained and/or converted.

Outsourcing

If your lab needs additional help in conducting research, there is a solution. Just as some sleep labs outsource their PSG scoring, the sleep lab can outsource its research tasks as well. From protocol procurement, to study coordinator, to PI training, site management organizations (SMOs) can help. The SMO will perform various tasks either on a fee-per-service or as a percentage of the total budget depending on the contract. Some labs use SMOs as a way to get their feet wet in research. Once the site feels proficient at conducting research, it may terminate its contract with the SMO. There are some sites that continue to use SMOs based on budget and staffing restrictions.

Funding

Two main sources of funds for conducting research are grants and contracts.

Grants are usually procured via nonprofit groups from organizations such as the National Institutes of Health (NIH). They vary in length of time and amount of money. Contracts are usually a product of clinical trials. These are made through for-profit organizations such as pharmaceutical or device companies that pay on an enrolled per-patient basis. The "sponsor" usually selects principal investigators from a pool of sites. The sponsor reviews the PI's training, experience, and enrollment numbers from past studies conducted. The sponsor also may review support staff training. Unlike grants, contracts through sponsors may be harder to obtain due to the fact that the sponsor has to be more selective. This has to do with the fact that unlike their grant counterparts, sponsor-based contracts are often on a stringent time line. Time lines may be set by the Food and Drug Administration (FDA) to gather data or by the sponsor in hopes of being first to market.

The NIH Web site explains grants and contacts as follows:

"NIH funds grants, cooperative agreements, and contracts that support the advancement of fundamental knowledge about the nature and behavior of living systems to meet the NIH mission of extending healthy life and reducing the burdens of illness and disability. While NIH awards many grants specifically for research, we also provide grant opportunities that support research-related activities, including: construction, training, career development, conferences, resource grants and more.

1. Projects of High Scientific Caliber
   NIH looks for grant proposals of high scientific caliber that are relevant to public health needs and are within NIH Institute and Center (IC) priorities. ICs highlight their research priorities on their Web sites. Applicants may want to contact the appropriate Institute or Center to discuss the relevancy and/or focus of the proposed research before submitting an application. NIH also has a number of broad NIH-wide initiatives that may be of interest.
2. Investigator-Initiated Research
   NIH strongly encourages investigator-initiated research across the spectrum of our mission. We issue hundreds of funding opportunity announcements (FOAs) in the form of Program Announcements (PAs) and requests for applications (RFAs) to stimulate research in particular areas of science. Some PAs, called ‘Parent Announcements,' span the breadth of the NIH mission in order to ensure we have a way to capture ‘unsolicited' applications that do not fall within the scope of targeted announcements. The majority of NIH applications are submitted in response to parent announcements.
3. Unique Research Projects
   Projects must be unique. By law, NIH cannot support a project already funded or pay for research that has already been done. Although you may not send the same application to more than one Public Health Service (PHS) agency at the same time, you can apply to an organization outside the PHS with the same application. If the project gets funded by another organization, however, it cannot be funded by NIH as well."

The Next Step

Before you can develop a proposal or begin speaking with sponsors to find out what they have in the pipeline, the sleep laboratory and staff must be prepared. Try to do as much preparatory research about research and become as well versed as possible. Speak with other people who conduct clinical studies and get their feedback. Finally, Web sites such as www.nih.gov or www.sleepresearchsociety.org can provide more information.

Patrick Moday, RPSGT, CCRC, is vice president of business development for Research In The Name Of Science Inc, a site management organization that specializes in helping investigators start research in their practice. Moday can be reached at .