Trial · NCT05154032
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Nocturnal Heart Rate as measured by OURA Ring | Daily from baseline through study completion at 8 weeks | Heart rate (beats per minute) will be quantified throughout the night via the OURA ring. |
| Primary | Change in Sleep Quantity as measured by Electroencephalography | Daily from baseline through study completion at 8 weeks | Sleep stage duration (and the cumulative sleep duration) will be quantified each night via the Dreem headband, which uses Electroencephalography (EEG) for automatic sleep stage scoring. |
| Primary | Change in Subjective Sleep Quality | Daily from baseline through study completion at 8 weeks | A custom daily morning questionnaire will be used to record how a participant feels the quality of their sleep was the previous night (e.g. 1, very poor; 10 excellent). This questionnaire will be taken on the participants smartphone within 30 minutes of waking. |
| Primary | Change in Nocturnal Heart Rate Variability as measured by OURA Ring | Daily from baseline through study completion at 8 weeks | Heart rate variability will be quantified throughout the night via the OURA ring. |
| Primary | Change in Anxiety surrounding Float-REST as measured by the State Trait Anxiety Index | Before and after each float session (Weeks 5-7) | Participants will complete the previously validated State Trait Anxiety Index (STAI) before and after each float session as a measure of subjective anxiety, where higher scores are suggestive of greater anxiety. State-Trait Anxiety Index (STAI) - Commonly used measure of state and trait anxiety, and done with 20 very brief questions. Values range from 20 to 80, with higher scores representing more severe anxiety. Participants will complete the STAI questionnaire before and after each session. The sessions will take place during weeks 5-7. |
| Primary | Change in heart rate during Float-REST as measured via Electrocardiography | During each float session (weeks 5-7) | Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session. |
| Primary | Change in heart rate variability during Float-REST as measured via Electrocardiography | During each float session (weeks 5-7) | Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session. |
| Secondary | Change in Subjective Athens Insomnia Scale measured via questionnaire | Weekly throughout study completion at 8 weeks | Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks). Athens Insomnia Scale (AIS) - eight-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = greater difficulty. |
| Secondary | Change in Subjective Epworth Sleepiness Scale measured via questionnaire | Weekly throughout study completion at 8 weeks | Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks). Epworth Sleepiness Scale (ESS) - eight-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = increased average sleep propensity in daily life |
| Secondary | Change in Subjective Insomnia Severity Index measured via questionnaire | Weekly throughout study completion at 8 weeks | Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks). Insomnia Severity Index (ISI) - seven-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = increased severity. |
| Secondary | Change in Subjective Restorative Sleep Questionnaire | Weekly throughout study completion at 8 weeks | Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks). Restorative Sleep Questionnaire (RSQ) - nine-item questionnaire assessing sleep behaviors on a scale of 0 to 5. Higher scores = better sleep |
| Secondary | Change in Subjective Patient Reported Outcomes Measurement Information System measured via questionnaire | Weekly throughout study completion at 8 weeks | Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks). Patient Reported Outcomes Measurement Information System (PROMIS) - seven item questionnaire assessing sleep behaviors on a scale of 0 to 5. Higher scores = healthier subject |
| Secondary | Subjective Sleep Preferences | Once at the beginning of week 1 | At intake, a custom baseline questionnaire will be completed to record each participants sleep preferences and common behaviors. These sleep preferences will be used to identify if Float-REST tends to be more or less successful for certain individuals based upon predetermined qualities. |
| Secondary | Subjective Success of Float-REST | Once at the end of week 8 | Following completion of the study, a custom questionnaire will record how successful the participant believes Float-REST was for improving their sleep and well-being. Participants will indicate how much they relate to a particular item on a scale of "Not at all" to "Very much so" |
| Secondary | Changes in Conflict Management via Questionnaire | Monthly from baseline through study completion at 8 weeks | Participants ability to manage conflict and the strategies in which they approach conflict will be assessed via the Conflict Management Questionnaire. This questionnaire scores the management of various situations based upon the participant responses (definitely true, true, tends to be true, tends not to be true, not true, definitely not true) and classifies the highest scoring response category as being the participant's preferred method of handing conflict. Scores of the response categories will be compared. |
| Secondary | Changes in Emotional Regulation as measured via Emotional Regulation Questionnaire | Monthly from baseline through study completion at 8 weeks | Participants' ability to regulate their emotions appropriately will be quantified via the previously validated Emotional Regulation Questionnaire (ERQ), in which participants will indicate how much they agree with each statement (1, strongly disagree; 7, strongly agree). |
| Secondary | Changes in Perceived Stress as measured via Perceived Stress Scale | Weekly from baseline through study completion at 8 weeks | Participants' perceived stress will be quantified via the previously validated Perceived Stress Scale (PSS), which asks participants to report on the frequency of various experiences (0, never; 4, very often) and final scoring suggests lower scores to be associated with lower levels of stress. |
| Secondary | Changes in Subjective Sleep as measured via Pittsburgh Sleep Quality Index | Monthly from baseline through study completion at 8 weeks | Participant's subjective reports of sleep quality will be quantified through the previously validated Pittsburgh Sleep Quality Index (PSQI). Questions are scored into multiple components to determine sleep difficulty in various areas, where higher scores are indicative of greater sleep difficulties; these scores will be compared across timepoints. |
| Secondary | Changes in Subjective Anxiety as measured via the State Trait Anxiety Index | Monthly from baseline through study completion at 8 weeks | Participants will complete the previously validated State Trait Anxiety Index (STAI) as a measure of subjective anxiety, where higher scores are suggestive of greater anxiety. |
| Secondary | Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire | Monthly from baseline through study completion at 8 weeks | Participants will complete a 34 item checklist that has been previously used for screening of a potential sleep disorder; the more items that the participant feels applies to them, the higher the likelihood of the individual having a sleep disorder. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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