Insomnia
Conditions
Brief summary
Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia
Interventions
BEHAVIORALSleep education and relaxation 1
Sleep hygiene and relaxation training; Sleep education and relaxation 1
BEHAVIORALSleep education and relaxation 2
Modified sleep hygiene and relaxation training; Sleep education and relaxation 2
Sponsors
Advanced Medical Electronics
Nalaka Gooneratne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Sleep onset latency \> 30 min for at least 3 nights per week
Exclusion criteria
1) Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages). 2) Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol). 3) History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder 4) Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep onset latency | four weeks | time to fall asleep |
Countries
United States
Outcome results
None listed