Insomnia Clinical Trial
— PECRMOfficial title:
Psychophysiological Effects of Controlled Respiration: Noninvasive Relaxation Techniques
NCT number | NCT05304000 |
Other study ID # | 41398 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2, 2020 |
Est. completion date | September 17, 2020 |
Verified date | May 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators aim to understand the effectiveness of 3 types of breathwork exercises and a mindfulness meditation control on improving psychological and physiological measures of wellbeing. The interventions will be delivered remotely and effects are monitored through daily surveys and physiological monitoring with WHOOP wristband through a 28-day period. The information gained will help develop the most effective remote interventions for lowering stress and improving wellbeing. The study will be run on a healthy general population. The three breathing conditions were 1) Cyclic Sighing, which emphasizes relatively prolonged exhalations, 2) Box Breathing, which is equal duration of inhalations, breath retentions, exhalations and breath retentions, and 3) Cyclic Hyperventilation with Retention, with longer, more intense inhalations and shorter, passive exhalations. Mindfulness Meditation practice involved passive attention to breath.
Status | Completed |
Enrollment | 108 |
Est. completion date | September 17, 2020 |
Est. primary completion date | September 17, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 - Not pregnant - Able to follow basic instruction for prescreen and scheduling - Compliant with investigator instructions during the consent process and participation in the study Exclusion Criteria: - Age <18 - Pregnant - Non-English speaking - Anyone with personality disorders or psychosis such as schizoaffective disorder - Demonstrates evidence of severe psychiatric disorder in prescreen or email contact (as judged by Dr. Spiegel) - Glaucoma - History of seizures - Suicidal - Heart disease (based on PI's clinical judgement, dependent on the severity of the symptoms) - Current untreated psychosis, or bipolar disorder, or substance/alcohol abuse/dependence (based on PI's clinical judgement, dependent on the severity of the symptoms) - Any Medical condition that could be exasperated by study participation (based on PI's clinical judgement) - Non USA mailing address to receive the WHOOP strap - Vision or hearing impairment severe enough to interfere with study participation, |
Country | Name | City | State |
---|---|---|---|
United States | Neurobiology and Ophthalmology | Palo Alto | California |
United States | Dept. of Psychiatry, Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Debriefing survey | Open ended survey about how subjects would describe the protocols | Day 29 (study endpoint) | |
Primary | State Anxiety | STAI State Trait Anxiety | Daily from Day 0 to 29 | |
Primary | Trait Anxiety | STAI State Trait Anxiety | Day 0 and Day 29 (Baseline and Endpoint) | |
Primary | Positive Affect | PANAS Positive Affect | Daily from Day 1 to 28 | |
Primary | Negative Affect | PANAS Negative Affect | Daily from Day 1 to 28 | |
Primary | Daytime Sleep Related Disturbance | PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Sleep Related Impairment Short Form 8a | Day 0 and Day 29 (Baseline and Endpoint) | |
Primary | Resting Heart Rate | Daily obtained from WHOOP wrist band | Daily from Day 1 to 28 | |
Primary | Heart Rate Variability | Daily obtained from WHOOP wrist band | Daily from Day 1 to 28 | |
Primary | Respiratory Rate | Daily obtained from WHOOP wrist band | Daily from Day 1 to 28 | |
Primary | Sleep Duration | Daily obtained from WHOOP wrist band | Daily from Day 1 to 28 | |
Primary | Change in number of hours of sleep | Daily obtained from WHOOP wrist band as Hours of Sleep. Changes in the hours of sleep will be assessed with more hours indicating better sleep. | Daily from Day 1 to 28 | |
Primary | Change in the ratio of number of hours of sleep to hours in bed | Obtained daily from WHOOP wrist band as sleep efficiency. Changes in the Whoop Sleep Efficiency score will be assessed with higher score (ratio) indicating higher sleep efficiency. | Daily from Day 1 to 28 | |
Secondary | Adherence to Protocol | Number of days subjects did their exercises out of the 28 days assigned | Daily from Day 1 to 28 |
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