legends · 5 min read ·
Participant Diary, Study 77-C
A sleep study participant keeps finding an extra tablet and a second sleeper who wakes at two for both of them.
**Clinical Study 77-C: Sleep Quality in Adults (Phase II, double-blind)**
**Participant ID:** 0412 · **Study site:** Ashmere Research Unit · **Week:** 3
*Participants must complete the daily diary and return all unused tablets at each visit. Please report any unusual experiences to the study nurse immediately.*
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**Dosing record — Week 3**
Day 15: Tablet taken 21:00. Dose: unknown (blinded).
Day 16: Tablet taken 21:00. Dose: unknown.
Day 17: Tablet taken 21:00. Dose: unknown.
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I joined the study because I haven't slept properly for three years. I wake up at two every morning, sometimes earlier, and lie in the dark listening to the flat. The fridge. The pipes. My own heart. The study offered a tablet that might help, blinded so no one, including me, knows whether I'm getting the real one or the placebo. I signed the consent form and was given a bottle with a number on it.
On the first night, the tablet tasted like chalk. On the second, nothing. On the third night I slept until seven, which hadn't happened since I was a student.
On the fourth morning I found a small white tablet on my bedside table. I didn't remember taking it out of the bottle. The bottle was full.
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**Participant diary — Day 19**
I'm meant to write the time I wake up. Two-fourteen. The same as always. I lay still and felt the mattress shift beside me, very slightly, the way it does when someone else is trying not to wake you.
I didn't turn over. I know the bed is only big enough for one.
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**Dosing record — Week 3 (continued)**
Day 19: Tablet taken 21:00. Note from participant: taste of chalk. Participant reports a second tablet was found on bedside table the next morning. Participant states it was not taken from the bottle.
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**Participant diary — Day 21**
I told the nurse about the second tablet. She was kind about it. She said some people feel they have an extra dose, and it's often because they're anxious about the trial. She asked whether I'd had any unusual experiences.
I said I'd been dreaming about a man in a wet coat, sitting on the end of my bed, asking me to wake up and come downstairs.
The nurse wrote it down. Then she asked me to describe his face.
I tried. But when I thought about his face I found I could see my own, very clearly, looking back at me from the foot of the bed, as if I were the one who had been asked to come down.
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**Participant diary — Day 24**
I've started to sleep through the night. Properly. I haven't woken at two since Day 17. I wake at seven, the alarm sounds, and I get up and make tea and feel better than I have in years.
But each morning there is one more tablet on the bedside table. The bottle still has the same number of pills, but the label has changed. It says the study is double-blind, and that I am receiving the active drug, and that my dose will be increased on Day 30.
I don't remember being told that.
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**Dosing record — Week 4**
Day 24: Tablet taken 21:00. Dose: increased (per label). Note from participant: label changed. Participant states she does not recall reading the new label.
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**Participant diary — Day 28**
I can hear him at night now. He doesn't come into the room. He stands on the landing, outside the door, and reads out a list of names. They're names I half know, from the street where I grew up, and when he gets to mine he stops, and waits, and then goes back to the start.
I haven't been able to find my mother's name in my memory for two days. I know the list. I just can't remember who wrote it.
When I went to the landing to look, the reading stopped, and the landing was empty, and there were two sets of footprints on the carpet, both going down the stairs toward the kitchen. The large ones were mine.
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**Study nurse's note (Day 30, Visit 4)**
Participant 0412 presented for her fourth visit. She was pale and alert, and reported sleeping well. She has no memory of taking tablets since Day 24, though her returned bottle shows the expected count. The bottle is full.
Participant asked whether the study drug could cause "a second sleeper." I told her that's not a recognised side effect. She asked me to write it down anyway.
Her blood pressure was unusually steady. Her heart rate, when I took it, was in perfect rhythm with a second pulse that I could feel faintly at her wrist, a fraction behind hers. I have never seen this in a trial.
I've recorded it under *other*.
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**Participant diary — Day 31**
I've been moved to the higher dose. I'm to take two tablets now, one at nine and one at two. I asked the nurse why the second one is at two, and she said it's to keep the dose even across the night.
I take them both. The chalk taste has gone. I sleep well. I don't wake at two, because I don't need to. There's someone in the room with me now, on the other side of the bed, and he wakes at two for both of us, and reads the names very softly, until I drift off.
I don't know his name. I've been trying to remember it.
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**Study closure notice (Ashmere Research Unit, Day 40)**
Participant 0412 has withdrawn from the study. She did not return her bottle. She did not attend Visit 5. Her last diary entry is dated Day 31.
The unit has reviewed her case. The study drug is not implicated in any serious adverse event. The participant's neighbour has reported that her flat is occupied, and that the light in the bedroom stays on all night, and that someone can be heard reading a list of names at two in the morning, very quietly, to a woman who will not stop asking to be let out.
The unit has asked the neighbour not to enter the flat.
*Participant 0412 is recorded as having completed the study. Her blood pressure at the final visit was steady. The second pulse was not recorded.*