Editor’s Note: Since November, I’ve been working on approval to participate in the ALKS 2680 Vibrance-3 clinical trial for Idiopathic Hypersomnia patients. IH is a rare, neurological sleep disorder similar to narcolepsy that is just now getting the attention it deserves. If you have IH or you have a loved one with IH, feel free to follow along here and on my Facebook page, Little Did She Know. To learn more about the clinical trial, visit ClinicalTrials.gov.
It is just after 1 AM on December 31st. If all goes well, in just under seven and a half hours, I’ll receive my first dose for the ALKS 2680 Vibrance-3 clinical trial for #IdiopathicHypersomnia (IH). I’m not nervous about side effects or scared it won’t work. It’s an odd peace, a calm that can only come from Jesus. I know God has me on this path for a purpose. Whether the drug helps, hurts or ends up ineffective like all the others I’ve tried, I’ve given it all over to God. I’m just going through the motions so He can do His work.
Then why am I up at 1 AM, writing about this, you ask? I’m not sure. Could be excitement. Could be the Twix I had before bed. Could be my secondary #DelayedSleepTendency sleep disorder. That’s right, your girl here has not one but two sleep disorders that feud like the Hatfields and the McCoys.
If you read my last post, “…What the ALKS 2680 Vibrance-3 Clinical Trial for IH Is,” you know it’s been a bit of a journey to get to this point in the study. I’ve made three trips to Cleveland Clinic specifically for this clinical trial so far: the initial physical exam/testing appointment, the eye exam required for the study and now a three-day sleep study appointment. I’ve also had to wear an actigraphy watch for the last 10 days, and I started my 14-day Adderall washout 18 days ago. So, let’s talk about this three-day visit and nearing the finish line on meeting the participation requirements.
L-R: On a flight to Akron after the Cleveland flight was cancelled, and arriving at the Cleveland Clinic main campus after a rocky start. Can you tell I was so tired that morning, I forgot to brush my hair?
I arrived in Cleveland on Monday, December 29. Getting here in itself was a side quest. I had to fly from Charleston, WV, to Charlotte to Cleveland – yes, I had to go south to go north – and upon arriving in Charlotte for my connection, the Cleveland flights were cancelled due to wind from the winter storm in the Great Lakes region. I was rerouted to Akron, Ohio, and then took a 48-minute Lyft ride with a lovely driver named Janelle. Considering I had been off my stimulant for 16 days at that point and had not had any caffeine in two days as a requirement of the sleep studies, I think I navigated that situation pretty well.
When I arrived on Monday, I did some additional questionnaires and last-minute prep work for the sleep studies in the clinical trial wing at the Cleveland Clinic. Then I checked into my hotel and took a nap before returning to the hospital for the scheduled polysomnography (PSG) and the maintenance of wakefulness test (MWT).
I mentioned in “…What the ALKS 2680 Vibrance-3 Clinical Trial for IH Is” that the PSG is the nighttime test given to diagnose sleep apnea, and it’s the first of two sleep studies used to diagnose narcolepsy and IH. If a patient passes the PSG, they stay in the clinic to continue an MSLT for Narcolepsy or IH diagnosis. This was my third PSG, and I passed it with flying colors.
In my last post, I explained that diagnosis also requires the multiple sleep latency test (MSLT), which is a series of nap opportunities spaced two hours apart over 8 to 10 hours during which the patient is in bed in a dark room and is told to try to go to sleep. During an MSLT, the following is measured: if the patient goes to sleep, how fast the patient goes to sleep, if the patient hits REM and how fast the patient hits REM. Each opportunity is 30 minutes, and if the patient falls asleep, they are allowed to sleep up to the 30-minute window.
Similarly, the MWT places the patient in a darkened room, sitting up in bed instead of lying down. Like the MSLT, this test is done every two hours over an 8 to 10 hour period. The test measures if the patient falls asleep and how quickly they fall asleep. As soon as the patient falls asleep, the test facilitator wakes them up. For both tests, the patient must stay awake for the time between each nap opportunity.
L-R: (Left) Tuesday morning, we removed all the wiring except the electrodes that measured brain activity necessary for the MWT. (Middle) After MWT nap #1; I don’t know if you can see how tired I was, but I fell asleep twice playing one of the brain games. I’ve never done that before. (Right) Dressed and ready to go back to the hotel after a grueling 24 hours of sleep tests.
During the MWT, they also had me doing tests – or brain games – on an iPad to check my memory skills and my response time while being without stimulants or naps. They will use the PSG and MWT results to confirm my diagnosis, get approval for my receiving the medication and document a baseline, and they will use the computer games throughout the clinical trial to look for any improvements while on the new drug as compared to the results taken during the MWT.
Later this morning, I’ll return to the clinic to find out if I’m approved to receive the medication in the blind study. We expect a yes, especially since I fell asleep within 5 to 10 minutes of lights out yesterday for three of the four naps (we had some outside stimulant interference that had an impact on the last nap). If we get the go, I’ll have another physical exam by a doctor this morning and complete more blood work and an EKG. I’ll then receive my first dose at 8:30 AM, and they will monitor me for a while after taking that dose because initial side effects with the first dose varied among narcolepsy patients, and I’ll be the first IH patient at Cleveland Clinic to receive the medication.
If approved to begin, I’ll report back to Cleveland Clinic every two weeks for an in-person check-up, additional testing like another eye exam and blood work and to receive the next two weeks’ worth of medication. The trial is a blind study, so no one knows if I will get an actual dosage of the medicine or a placebo. In about 8 weeks, I’ll have to come back and do another sleep study test series to compare results.
When I agreed to this trial, I knew there would be a lot of visits to Cleveland. I didn’t remember what it felt like to not be on Adderall, and while I knew coming off of it in the washout would be hard, I underestimated how hard that would be. I’ve been a complete zombie since I came off the Adderall, napping two and three times a day, and it’s still not enough. The sleep inertia is terrible, my productivity for everything is low, and I am irritable. But I trust God to see me through this.
Because here’s the thing. After God moved mountains for me in hurricane season, I know without a doubt He’s got my back. He’s already at the end of this study. He’s already fought the battle for me. Whatever happens – whether this drug helps or doesn’t – He’s already got it all worked out. I feel like He’s leading me into this study, and something really special is going to come out of it. (Read about God moving mountains in hurricane season here: “…She’d See God Move Mountains.”)
Trust me, kid. I’ve got you.
I don’t like flying, and the flight into Akron was particularly rocky. To distract myself, I stuck an earbud in my ear and turned on my “God” playlist on my phone. I heard a really cool song by Anne Wilson that I had never listened to before, and I want to share it with you. The song is called “Scatter,” and the lyrics say:
“Before I hit the front line, You’ve already gone before. I know that I know the battle is the Lord’s.”
Little Did She Know 