NCT06218186 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Raphelson JR, Ahmed IM, Ancoli-Israel S, Ojile J, Pearson S, Bennett N, Uhles ML, Rohrscheib C, Malhotra A
Evaluation of a novel device to assess obstructive sleep apnea and body position. J Clin Sleep Med. 2023 Sep 1;19(9):1643-1649. doi: 10.5664/jcsm.1
Zandieh S, Kirschenbaum MA, Greenberg H, Ancoli-Israel S
Keep it simple: A novel technique for measuring airflow using a wireless patch. Sleep Health. 2023 Feb;9(1):100-107. doi: 10.1016/j.sleh.2022.10.005. Epub 2022 Dec 5.

A Single Arm Quantitative Study Assessing Performance of Wesper Lab as a Tool to Aid in Sleep Apnea Diagnosis in Pediatric Populations

Clinical trial NCT06218186 - References