None listed
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Not Applicable: Not Applicable
Sponsors
1008 Digital Health Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Group 1 Insomnia and Group 2 Sleep Apnea 1 Adults aged 18 to 70 years 2 Diagnosed with insomnia as defined by DSM-5 criteria 3 Participants diagnosed with sleep apnea must have an AHI score of 5 or higher to meet the diagnostic criteria 4 Ability to provide informed consent 5 No other significant sleep disorders like narcolepsy 6 Willingness to wear the Aabo ring consistently throughout the study duration 7 Access to a smartphone or compatible device for data management Group 3 Stress and Anxiety 1 Adults aged 18 to 70 years 2 Self reported levels of stress or anxiety that meet moderate to high thresholds assessed using validated questionnaires 3 No acute psychiatric conditions that would require immediate intervention 4 Access to a smartphone or compatible device for data management Group 4 Women s Health 1 Menstruating woman aged between 18 to 45 years 2 Regular menstrual cycles lasting 21-35 days without significant irregularities 3 Ability to provide informed consent 4 Not currently using hormonal contraceptives or undergoing hormone therapy that would alter the menstrual cycle 5 Willingness to wear the Aabo ring throughout one complete menstrual cycle 6 Access to a smartphone or compatible device for data management
Exclusion criteria
Exclusion criteria: Group 1 Insomnia and Group 2 Sleep Apnea 1 Current use of sleep medications or supplements that may interfere with sleep patterns 2 Presence of other significant psychiatric or neurological disorders 3 Pregnancy or lactation as these can affect sleep patterns 4 Any recent changes in lifestyle that could impact sleep like major stressors or travel 5 Inability to comply with study protocols or follow up assessments 6 Restrictions regarding physical activity Group 3 Stress and Anxiety 1 Current treatment for acute stress reactions or severe anxiety disorders 2 History of substance abuse within the past year 3 Significant medical conditions affecting stress responses like chronic illnesses 4 Pregnant or nursing women 5 Inability to commit to wearing the Aabo ring consistently Group 4 Women s Health 1 Those with diagnosed hormonal disorders such as polycystic ovary syndrome or thyroid dysfunction 2 Pregnant or nursing women 3 Recent surgeries affecting the reproductive system 4 Current use of medications affecting hormonal levels or menstrual regularity 5 Inability to comply with wearing the Aabo ring or participating in the study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group 1: Insomnia 1. Monitor sleep patterns, including total sleep time, quality sleep time, deep sleep time and heart rate dip. Group 2: Sleep Apnea 1. Monitor respiratory parameters namely respiratory rate and SpO2 (blood oxygen saturation) levels. Group 3: Stress and Anxiety 1. Monitor trends in stress levels using heart rate variability (HRV), resting heart rate, basal temperature, and sleep patterns. Group 4: Women s Health 1. Monitor changes in basal body temperature across different phases of the menstrual cycle. Timepoint: Group I - Day 1 to Day 15 Group II- Day 1 & Day 15 Group III- Day 1 to Day 15 Group IV- Day 1 to Day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assess user acceptance and adherence to wearing the Aabo ring consistently during sleep. 2. Compare sleep data from the Aabo ring with scores from the Pittsburgh Sleep Quality Index (PSQI). 3.Compare stress and anxiety data from the Aabo ring with self-reported levels of stress and anxiety, measured using the GAD-7 Anxiety Scale and the Perceived Stress Scale (PSS). 4.Compare the women s health data from the Aabo ring with Menstrual Distress Questionnaire (MEDI-Q).Timepoint: 1. Day 1 to Day 15 for Group I, II, III. Day 1 to Day 35 for Group IV 2. Day 15 for Group I, II 3. Day 1 & Day 15 for Group III 4. Day 35 for Group IV | — |
Countries
India
Contacts
Public ContactMeena Dalal
1008 Digital Health Pvt Ltd
Outcome results
None listed