Psychophysiological Effects of Controlled Respiration and Mindfulness

NCT05304000 | Completed

• 1 other identifier: 41398
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stress, Physiological; Stress, Emotional; Insomnia

Keywords

stress; breathwork; mindfulness meditation; mood; anxiety; wearable; physiology

Outcome Measures

Primary Outcomes (11)

• State Anxiety

  STAI State Trait Anxiety

  Daily from Day 0 to 29

• Trait Anxiety

  STAI State Trait Anxiety

  Day 0 and Day 29 (Baseline and Endpoint)

• Positive Affect

  PANAS Positive Affect

  Daily from Day 1 to 28

• Negative Affect

  PANAS Negative Affect

  Daily from Day 1 to 28

• 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)

• Resting Heart Rate

  Daily obtained from WHOOP wrist band

  Daily from Day 1 to 28

• Heart Rate Variability

  Daily obtained from WHOOP wrist band

  Daily from Day 1 to 28

• Respiratory Rate

  Daily obtained from WHOOP wrist band

  Daily from Day 1 to 28

• Sleep Duration

  Daily obtained from WHOOP wrist band

  Daily from Day 1 to 28

• 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

• 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 Outcomes (1)

• Adherence to Protocol

  Daily from Day 1 to 28

Other Outcomes (1)

• Debriefing survey

  Day 29 (study endpoint)

Study Arms (4)

Mindfulness Meditation

ACTIVE COMPARATOR

5 minutes a day of mindfulness meditation practice for 28 days (passive attention to breath) delivered remotely through a video link.

Behavioral: Mindfulness Meditation

Cyclic Sighing Breathing

EXPERIMENTAL

5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of slow inhales until lungs felt full then one more inhale to maximally fill the lungs, followed up a slow exhale. Repeat this cycle for 5 minutes.

Behavioral: Cyclic Sighing Breathing

Box Breathing

EXPERIMENTAL

5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of equal duration of inhale, hold, exhale, hold cycles. The duration of the cycle is determined by the participant's comfort level with holding. (e.g. 4 sec inhale, 4 sec hold, 4 sec exhale, 4 sec hold). Repeat this cycle for 5 minutes.

Behavioral: Box Breathing

Cyclic Hyperventilation with Retention

EXPERIMENTAL

5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of 30 breaths (inhale deeply through the nose and exhale passively through the mouth) and after those 30 breaths, to exhale all their air via their mouth and to calmly wait with lungs empty for 15 seconds. Repeat this cycle for 5 minutes.

Behavioral: Cyclic Hyperventilation with Retention

Interventions

Mindfulness Meditation BEHAVIORAL

Participants are informed they should sit down in a chair or, if they preferred, to lie down, and then to set a timer for 5 minutes. Then they are told to close their eyes and to start breathing while focusing their mental attention on their forehead region between their two eyes. They are told that if their focus drifted from that location to re-recenter their attention by focusing back first on their breath and then on the forehead region between their eyes. They are told that as thoughts arise, to recognize that as normal, refocus their attention back to their forehead region and to continue the practice until time has elapsed.

Mindfulness Meditation

Cyclic Sighing Breathing BEHAVIORAL

Participants are informed they should sit down in a chair or, if they prefer, to lie down, and to set a timer for 5 minutes. Then they are told to inhale slowly, and that once their lungs are expanded, to inhale again once more to maximally fill their lungs -- even if the second inhale was shorter in duration and smaller in volume than the first, and then to slowly and fully exhale all their breath. They are told to repeat this pattern of breathing for 5 minutes. They are also informed that ideally, both inhales would be performed via their nose and the exhale would be performed via their mouth, but that if they preferred, they are welcome to do the breathing entirely through their nose. They are also informed that it is normal for the second inhale to be briefer than the first.

Cyclic Sighing Breathing

Box Breathing BEHAVIORAL

Participants are informed they should sit down in a chair or lie down, and to get a timer. Then they are told to take the "CO2 tolerance test" as follows: Take 4 breaths through the nose. Then take a maximally deep breath and once your lungs are full, exhale as slowly as possible through your nose or mouth. Time how long it takes to empty your lungs; this will be your C02 discard duration. Use your discard duration to determine how long your inhales, exhales, and breath holds should be (CO2 discard time) by using this table: \<20 sec = 3 - 4 sec, 25 - 45 sec = 5 - 6 sec, 50 - 75+ sec = 8 -10 sec. They are then told to inhale, hold, exhale, hold (for the duration determined by the C02 discard table) and to repeat this pattern for the entire 5 minutes. If at any point they had to strain to reach these times, they should simply reduce the duration of inhales, exhales, and breath holds. We ask participants to perform all breathing through their nose, if possible.

Box Breathing

Cyclic Hyperventilation with Retention BEHAVIORAL

Participants are informed they should sit down in a chair or, if they prefer, to lie down, and to set a timer for 5 min. Then they are told to inhale deeply (ideally through their nose but if that is not possible, to inhale through their mouth) and then exhale by passively letting the air "fall out from the mouth". We inform them that for sake of this protocol, that pattern of a deep inhale through the nose and passively letting the air "fall out from the mouth" = 1 breath. Then they are instructed to perform 30 breaths (in and out) in this manner, and after those 30 breaths, to exhale all their air via their mouth and to calmly wait with lungs empty for 15 seconds.

Cyclic Hyperventilation with Retention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Neurobiology and Ophthalmology

Palo Alto, California, 94304, United States

Location

Dept. of Psychiatry, Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David Spiegel, M.D.

  Professor of Psychiatry, Stanford University

  PRINCIPAL INVESTIGATOR

• Andrew Huberman, Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

• Manuela Kogon, M.D.

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and Behavioral Sciences, Stanford University

Model Details: Randomized prospective

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 31, 2022
• Study Start: June 2, 2020
• Primary Completion: September 17, 2020
• Study Completion: September 17, 2020
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)