<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04455971</url>
  </required_header>
  <id_info>
    <org_study_id>OMSLEEP</org_study_id>
    <nct_id>NCT04455971</nct_id>
  </id_info>
  <brief_title>Orgasmic Meditation and Sleep Quality</brief_title>
  <official_title>A Naturalistic, Longitudinal, Observational Study of Associations Between Frequency of Orgasmic Meditation Practice, Occurrence of Female Physiological Orgasm and Sleep Quality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of OM Foundation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of OM Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to use an observational design to examine whether the&#xD;
      practice of orgasmic meditation (OM) is associated with app-based measures of sleep quality.&#xD;
      A secondary purpose of this study is to examine whether the occurrence of physiological&#xD;
      orgasm during OM practice is associated with app-based measures of sleep quality. It is&#xD;
      hypothesized that the practice of OM will have a positive impact on sleep quality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 6, 2020</start_date>
  <completion_date type="Actual">April 15, 2021</completion_date>
  <primary_completion_date type="Actual">April 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between sleep quality and occurrence and frequency of OM sessions during the prior day</measure>
    <time_frame>30 days</time_frame>
    <description>&quot;Sleep quality&quot; will be measured using the Sleep Cycle app</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between sleep duration and occurrence and frequency of OM sessions during the prior day</measure>
    <time_frame>30 days</time_frame>
    <description>&quot;Sleep duration&quot; will be measured using the Sleep Cycle app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between time to fall asleep and occurrence and frequency of OM sessions during the prior day</measure>
    <time_frame>30 days</time_frame>
    <description>&quot;Time to fall sleep&quot; will be measured using the Sleep Cycle app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between sleep regularity and occurrence and frequency of OM sessions during the prior day</measure>
    <time_frame>30 days</time_frame>
    <description>&quot;Sleep regularity&quot; will be measured using the Sleep Cycle app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total sleep duration during nights following OM and nights following no OM</measure>
    <time_frame>30 days</time_frame>
    <description>&quot;Sleep duration&quot; will be measured using the Sleep Cycle app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in time to fall asleep during nights following OM and nights following no OM</measure>
    <time_frame>30 days</time_frame>
    <description>&quot;Time to fall sleep&quot; will be measured using the Sleep Cycle app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep regularity during nights following OM and nights following no OM</measure>
    <time_frame>30 days</time_frame>
    <description>&quot;Sleep regularity&quot; will be measured using the Sleep Cycle app</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">46</enrollment>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>OM Group</arm_group_label>
    <description>People who participate in the practice of orgasmic meditation (OM)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Orgasmic Meditation</intervention_name>
    <description>Orgasmic Meditation (OM) is a form of meditation that increases bodily awareness during structured, partnered female genital stimulation over a 15-minute period.</description>
    <arm_group_label>OM Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥18 years old, males and females, no exclusion by race, ethnicity or sexual&#xD;
             orientation&#xD;
&#xD;
          2. Experienced in OM practice (&quot;experienced&quot; defined as &gt;10 OM sessions in lifetime)&#xD;
&#xD;
          3. Currently practicing OM and participating in ≥1 OM session per week on average&#xD;
&#xD;
          4. Willingness to calibrate the Sleep Cycle app and use it for 30 continuous nights&#xD;
&#xD;
          5. Ability to charge phone by bed overnight during sleep&#xD;
&#xD;
          6. Ability to place phone near the bed, such as on a nightstand table overnight during&#xD;
             sleep&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Inability to speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Raison, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of OM Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of OM Foundation</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>May 7, 2021</last_update_submitted>
  <last_update_submitted_qc>May 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04455971
org study id: OMSLEEP
nct id: NCT04455971
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary purpose of this study is to use an observational design to examine whether the
      practice of orgasmic meditation (OM) is associated with app-based measures of sleep quality.
      A secondary purpose of this study is to examine whether the occurrence of physiological
      orgasm during OM practice is associated with app-based measures of sleep quality. It is
      hypothesized that the practice of OM will have a positive impact on sleep quality.
observational model: Cohort
time perspective: Prospective
measure: Correlation between sleep quality and occurrence and frequency of OM sessions during the prior day
time frame: 30 days
description: "Sleep quality" will be measured using the Sleep Cycle app
measure: Correlation between sleep duration and occurrence and frequency of OM sessions during the prior day
time frame: 30 days
description: "Sleep duration" will be measured using the Sleep Cycle app
measure: Correlation between time to fall asleep and occurrence and frequency of OM sessions during the prior day
time frame: 30 days
description: "Time to fall sleep" will be measured using the Sleep Cycle app
measure: Correlation between sleep regularity and occurrence and frequency of OM sessions during the prior day
time frame: 30 days
description: "Sleep regularity" will be measured using the Sleep Cycle app
measure: Change in total sleep duration during nights following OM and nights following no OM
time frame: 30 days
description: "Sleep duration" will be measured using the Sleep Cycle app
measure: Change in time to fall asleep during nights following OM and nights following no OM
time frame: 30 days
description: "Time to fall sleep" will be measured using the Sleep Cycle app
measure: Change in sleep regularity during nights following OM and nights following no OM
time frame: 30 days
description: "Sleep regularity" will be measured using the Sleep Cycle app
arm group label: OM Group
description: People who participate in the practice of orgasmic meditation (OM)
intervention type: Behavioral
intervention name: Orgasmic Meditation
description: Orgasmic Meditation (OM) is a form of meditation that increases bodily awareness during structured, partnered female genital stimulation over a 15-minute period.
arm group label: OM Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Raison, MD
role: Principal Investigator
affiliation: Institute of OM Foundation
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No