Trial · NCT03774810
Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia
NCT03774810, Phase 4, Completed, University of Pennsylvania; results first posted 2025-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia. Trials, record NCT03774810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03774810
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia
- NCT number
- NCT03774810
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 197 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Insomnia, Insomnia Chronic
- Interventions
- Zolpidem tartrate
- First posted
- 2018-12-13
- Last updated
- 2025-05-09
- Results first posted
- 2025-05-09
- Limitations and caveats
The following results are preliminary and do not take into account post-randomization factors such as missing data, dropout, or adherence to the intervention regimens. Accordingly, the results are considered preliminary and will be updated on or before the new year (2025).
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Response (Phase 1) | 1 Month | Tracking treatment response via assessing daily sleep continuity (sleep latency, wake after sleep onset, and early morning awakenings). |
| Primary | Insomnia Relapse (Phase 2) | 3 months | Tracking relapse via assessing daily sleep continuity (sleep latency, wake after sleep onset, and early morning awakenings). |
| Primary | Insomnia Relapse (Phase 3) | 9 months | Tracking relapse via assessing daily sleep continuity (sleep latency, wake after sleep onset, and early morning awakenings). |
| Secondary | Sleep Continuity (Phase 1) | 1 Month | Assess sleep continuity by assessing daily sleep diary responses. |
| Secondary | Sleep Continuity (Phase 2) | 3 months | Assess sleep continuity by assessing daily sleep diary responses. |
| Secondary | Sleep Continuity (Phase 3) | 9 months | Assess sleep continuity by assessing daily sleep diary responses. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Response (Phase 1) | 1 Month | All subjects received the same treatment for phase 1, so none were randomized to other conditions. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Insomnia Relapse (Phase 2) | 3 months | This outcome only includes phase 2, so, by definition the phase 1 group had no subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sleep Continuity (Phase 1) | 1 Month | This outcome only includes phase 1, so, by definition the groups for phases 2 and 3 had no subjects. | Minutes | MEAN |
| SECONDARY | Sleep Continuity (Phase 2) | 3 months | This outcome only includes phase 2, so, by definition the phase 1 group had no subjects. | Minutes | MEAN |
| SECONDARY | Sleep Continuity (Phase 3) | 9 months | This outcome only includes phase 3, so, by definition the phase 1 group had no subjects. | Minutes | MEAN |
| PRIMARY | Insomnia Relapse (Phase 3) | 9 months | This outcome only includes phase 3, so, by definition the phase 1 group had no subjects. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Response (Phase 1) | QHS-FD (Phase 1) | 94 | Participants | ||
| Insomnia Relapse (Phase 2) | Partial Reinforcement 1 (PR1) (Phases 2 & 3) | 4 | Participants | ||
| Insomnia Relapse (Phase 2) | Partial Reinforcement 3 (PR3) (Phases 2 & 3) | 3 | Participants | ||
| Insomnia Relapse (Phase 2) | Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3) | 3 | Participants | ||
| Insomnia Relapse (Phase 2) | Full Dose Nightly (QHS-FD) (Phases 2 & 3) | 1 | Participants | ||
| Sleep Continuity (Phase 1) | QHS-FD (Phase 1) | Sleep Latency (SL) | 17.35 | Standard Deviation 26.09 | Minutes |
| Sleep Continuity (Phase 1) | QHS-FD (Phase 1) | Wake After Sleep Onset (WASO) | 29.46 | Standard Deviation 34.82 | Minutes |
| Sleep Continuity (Phase 1) | QHS-FD (Phase 1) | Early Morning Awakenings (EMA) | 69.07 | Standard Deviation 52.45 | Minutes |
| Sleep Continuity (Phase 2) | Partial Reinforcement 1 (PR1) (Phases 2 & 3) | Sleep Latency (SL) | 21.24 | Standard Deviation 26.51 | Minutes |
| Sleep Continuity (Phase 2) | Partial Reinforcement 3 (PR3) (Phases 2 & 3) | Sleep Latency (SL) | 24.56 | Standard Deviation 45.02 | Minutes |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | QHS-FD (Phase 1) | 115 | |
| Phase 1 | STARTED | Partial Reinforcement 1 (PR1) (Phases 2 & 3) | 0 | |
| Phase 1 | STARTED | Partial Reinforcement 3 (PR3) (Phases 2 & 3) | 0 | |
| Phase 1 | STARTED | Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3) | 0 | |
| Phase 1 | STARTED | Full Dose Nightly (QHS-FD) (Phases 2 & 3) | 0 | |
| Phase 1 | COMPLETED | QHS-FD (Phase 1) | 83 | |
| Phase 1 | COMPLETED | Partial Reinforcement 1 (PR1) (Phases 2 & 3) | 0 | |
| Phase 1 | COMPLETED | Partial Reinforcement 3 (PR3) (Phases 2 & 3) | 0 | |
| Phase 1 | COMPLETED | Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3) | 0 | |
| Phase 1 | COMPLETED | Full Dose Nightly (QHS-FD) (Phases 2 & 3) | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events95
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Brain Fog | Nervous system disorders | QHS-FD (Phase 1) | 0 | 115 | 0 |
| other | Brain Fog | Nervous system disorders | Partial Reinforcement 1 (PR1) (Phases 2 & 3) | 0 | 22 | 0 |
| other | Brain Fog | Nervous system disorders | Partial Reinforcement 3 (PR3) (Phases 2 & 3) | 0 | 18 | 0 |
| other | Brain Fog | Nervous system disorders | Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3) | 0 | 23 | 0 |
| other | Brain Fog | Nervous system disorders | Full Dose Nightly (QHS-FD) (Phases 2 & 3) | 1 | 20 | 1 |
| other | Dizziness | Nervous system disorders | QHS-FD (Phase 1) | 1 | 115 | 1 |
| other | Dizziness | Nervous system disorders | Partial Reinforcement 1 (PR1) (Phases 2 & 3) | 0 | 22 | 0 |
| other | Dizziness | Nervous system disorders | Partial Reinforcement 3 (PR3) (Phases 2 & 3) | 1 | 18 | 1 |
| other | Dizziness | Nervous system disorders | Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3) | 1 | 23 | 1 |
| other | Dizziness | Nervous system disorders | Full Dose Nightly (QHS-FD) (Phases 2 & 3) | 2 | 20 | 2 |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QHS-FD (Phase 1) | 0 | 115 |
| Total, all-cause mortality | Partial Reinforcement 1 (PR1) (Phases 2 & 3) | 0 | 22 |
| Total, all-cause mortality | Partial Reinforcement 3 (PR3) (Phases 2 & 3) | 0 | 18 |
| Total, all-cause mortality | Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3) | 0 | 23 |
| Total, all-cause mortality | Full Dose Nightly (QHS-FD) (Phases 2 & 3) | 0 | 20 |
| Total, other adverse events | QHS-FD (Phase 1) | 2 | 115 |
| Total, other adverse events | Partial Reinforcement 1 (PR1) (Phases 2 & 3) | 4 | 22 |
| Total, other adverse events | Partial Reinforcement 3 (PR3) (Phases 2 & 3) | 7 | 18 |
| Total, other adverse events | Low Frequency Intermittent Dosing (IDS-FD) (Phases 2 & 3) | 2 | 23 |
| Total, other adverse events | Full Dose Nightly (QHS-FD) (Phases 2 & 3) | 7 | 20 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AG054521 | Three Approaches to Maintenance Therapy for Chronic Insomnia in Older Adults | PERLIS, MICHAEL LLOYD | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE ON AGING | 2018 to 2021 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03774810
GET https://conductscience.org/api/trials/v1/NCT03774810/results?page=2