N/A
Completed N=35
Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
Stress Disorders, Post-Traumatic · Sleep Initiation and Maintenance Disorders
Source: ClinicalTrials.gov NCT00868517 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Perceived Sleep Quality — 2.8; 2.6; 2.3; 2.8 units on a scale
Summary
The purpose of this study was to examine if group ear acupuncture improves Post-Traumatic Stress Disorder sleep difficulties among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study also examined the degree of veteran acceptance for a group ear acupuncture procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perceived Sleep Quality |
2.8; 2.6; 2.3; 2.8; 2.8; 2.4 | — |
| SECONDARY Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps |
303.8; 397.3; 378.8; 26.6; 31; 34.4 | — |
| SECONDARY Hypnotic Medication Use |
0; 1; 0; 1; 0; 0 | — |
| SECONDARY Attrition Rates |
68.0; 60.2 | — |
| SECONDARY Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture |
8; 7; 8; 8 | — |
| SECONDARY Fragmented Sleep Patterns-Sleep Efficiency |
77.3; 81; 80.8; 77.9; 83.1; 79.7 | — |
Eligibility Criteria
Inclusion Criteria
- Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts;
- Diagnosed with Post Traumatic Stress Disorder (PTSD) per Diagnostic Statistical Manual (DSM) IV criteria;
- Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI);
- Diagnosis of insomnia made after PTSD diagnosis; and
- If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study.
Exclusion Criteria
- Does not speak English;
- Not competent to sign informed consent;
- History of moderate or severe traumatic brain injury
- Start use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) during the study.
- Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis;
- History of substance abuse Dependence (as defined per DSM IV criteria) during the one year preceding enrollment in the study OR history of illicit substance use for 3 months prior to study enrollment OR positive Audit C score at study enrollment (defined as score of 5 and above).
- Received acupuncture during past 3 months.
- On Coumadin, Heparin, or Lovenox
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00868517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.